Ottawa Hospital’s chief ethicist terminated from job — but it’s unclear why (media)

media

 ...While bioethicists employed as professors in universities are protected by academic privilege, the same is not true for those who work for other institutions, and they may sometimes run afoul of senior administrators and donors, said Somerville, who is now a professor of bioethics at the University of Notre Dame Australia.

And yet an ethicist “can be the last barrier to something done wrong. They are the safeguard that everything is being done in an ethical way,” said Somerville, who is now a professor of bioethics at the University of Notre Dame Australia.
“When an ethicist is suddenly terminated with no warning and no cause given, and is known to be working in a very controversial area, then you have to know why they they have lost their job.”

Survival Comparison Between Endoscopic and Surgical Management for Upper Tract Urothelial Cancer (+ comment/SEER data etc)

PracticeUpdate

Find NCI-Supported Clinical Trials - National Cancer Institute (my test of 2 cancers)

Find NCI-Supported Clinical Trials

NCI-supported clinical trials are those sponsored or otherwise financially supported by NCI.

Search Tip: For more search options, use our advanced search.

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Your age helps determine which trials are right for you.


(my) test: 

#1. No Trials Matched Your Search

No clinical trials matched your search for Type/Condition: "Ureter Cancer", within 100 miles of ZIP: "xxxxx", Age: "xx".

For assistance, please contact our Cancer Information Service. You can chat online or call 1-800-4-CANCER (1-800-622-6237).

#2. 

Results 1-3 of 3 for: Type/Condition: "Ovarian Epithelial Cancer", within 100 miles of ZIP: "xxxxx", Age: "xx"

(new) NCI Cancer Clinical Trials API - National Cancer Institute

National Cancer Institute

 NCI's clinical trial search is now powered by the beta version of the Clinical Trials API and allows NCI to begin providing better search results. The information made publicly available by the Clinical Trials API draws from the Clinical Trials Reporting Program (CTRP) database.

NIH (U.S.) HHS takes steps to provide more information about clinical trials to the public

HHS takes steps to provide more information about clinical trials to the public
 Friday, September 16, 2016

In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule (link is external) that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products. At the same time, the National Institutes of Health has issued a complementary policy (link is external) for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.
“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”

(UK) Bevacizumab for Ovarian Cancer at High Risk of Progression: Reproducibility of Trial Results in ‘Real-world’ Patients

abstract

 Bevacizumab has become a ‘community standard’ at many UK centres as part of first-line treatment of patients with ovarian cancer at high risk of progression [International Federation of Gynecology and Obstetrics (FIGO) stage IV, or suboptimally debulked stage III] based on the results of phase III trials such as ICON-7. Its impact in patients treated outside clinical trials is, however, still unknown. In this study, we investigated patient characteristics, treatment patterns, adverse events and progression-free survival in ‘real-world’ patients in South West Wales. A total of 60 patients, treated between 2012 and 2015, were included in the study. Patient characteristics were less favourable compared to the bevacizumab-treated high-risk group in the ICON-7 trial (median age: 66 vs. 60 years; stage IV: 58% vs. 42%; performance status 0: 18% vs. 41%); 75% had received neoadjuvant chemotherapy before starting bevacizumab. After a median treatment duration of 8 months (range=0-34 months), 45 patients (75%) had experienced disease progression and 34 (56.7%) had died. Median progression-free survival was 16 months (95% confidence interval=14.4-17.6 months). The most common toxicities consisted of proteinuria (66.7%, all grade 1) and grade 1-2 hypertension (15%). Cardiovascular incidents, two of which were fatal, occurred in 6.7% of patients. In conclusion, our study provides encouraging evidence that the routine use of bevacizumab as part of first-line treatment of patients with ovarian cancer at high risk of progression may be associated with outcomes comparable with those obtained in clinical trials.

Ovarian carcinoma diagnosis: the clinical impact of 15 years of change

Abstract
 

Background:

Until recently ovarian carcinoma was considered to be a single disease, and treatment decisions were based solely on grade and pre- and postoperative tumour burden. New insights into molecular features, treatment response, and patient demographics led the scientific community to conclude that ovarian carcinoma histotypes are different disease entities.

Methods:

In 2002, the pathology specimens from patients in a clinical trial were reviewed by an experienced gynaecopathologist (pathologist A) for translational research purposes. All cases were typed according to what were then current criteria. The identical cohort was now reassessed by the same expert pathologist and independently reviewed by another gynaecopathologist (pathologist B) applying WHO 2014 diagnostic criteria. Survival analyses were done based on the original as well as the new diagnoses, and historical biomarker study results were recalculated.

Results:

Upon re-review, pathologist A rendered the same histotype diagnosis in only 54% of cases. In contrast, pathologists A and B independently rendered the same diagnosis in 98% of cases. Histotype was of prognostic significance when 2014 diagnoses were used, but was not prognostic using the original (2002) histotype diagnoses.

Conclusions:

Our study demonstrates a marked shift in ovarian carcinoma histotype diagnosis over the past 15 years. The new criteria are associated with a very high degree of interobserver reproducibility, allowing for treatment decisions based on histotype. Finally, biomarkers of putative prognostic significance were revealed to be primarily histotype-specific markers, confirming the critical importance of obtaining up-to-date diagnoses rather than accepting archival histotype data in clinical research.

Dietary exposure to polychlorinated biphenyls and risk of breast, endometrial and ovarian cancer in a prospective cohort

Abstract

Background:

Observational studies on polychlorinated biphenyl (PCB) exposure and hormone-related cancer risk are either inconsistent or lacking. We aimed to assess associations of dietary PCB exposure with breast, endometrial and ovarian cancer risk in middle-aged and elderly women.

Methods:

We included 36 777 cancer-free women at baseline in 1997 from the prospective population-based Swedish Mammography Cohort. Validated estimates of dietary PCB exposure were obtained via a food frequency questionnaire. Incident cancer cases were ascertained through register linkage.

Results:

During 14 years of follow-up, we ascertained 1593, 437 and 195 incident cases of breast, endometrial and ovarian cancer. We found no overall association between dietary PCB exposure and any of these cancer forms. The multivariable-adjusted relative risks comparing women in the highest and lowest tertile of PCB exposure were 0.96 (95% confidence interval (CI): 0.75, 1.24), 1.21 (95% CI: 0.73, 2.01) and 0.90 (95% CI: 0.45, 1.79) for breast, endometrial and ovarian cancer. In analyses stratified by factors influencing oestrogen exposure, possibly masking associations with PCBs, indications of higher risks were observed for endometrial cancer.

Conclusions:

This study suggests that dietary exposure to PCBs play no critical role in the development of breast, endometrial or ovarian cancer during middle-age and old ages.

Assessment of the InSiGHT Interpretation Criteria for the Clinical Classification of 24 MLH1 and MSH2 Gene Variants

abstract:
Assessment of the InSiGHT Interpretation Criteria for the Clinical Classification of 24 MLH1 and MSH2 Gene Variants
15 SEP 2016

Pathogenicity assessment of DNA variants in disease genes to explain their clinical consequences is an integral component of diagnostic molecular testing. The International Society for Gastrointestinal Hereditary Tumors (InSiGHT) has developed specific criteria for the interpretation of mismatch repair (MMR) gene variants. Here, we performed a systematic investigation of 24 MLH1 and MSH2 variants. The assessments were done by analyzing population frequency, segregation, tumor molecular characteristics, RNA effects, protein expression levels and in vitro MMR activity. Classifications were confirmed for 15 variants and changed for 3, and for the first time determined for 6 novel variants. Overall, based on our results we propose the introduction of some refinements to the InSiGHT classification rules. The proposed changes have the advantage of homogenizing the InSIGHT interpretation criteria with those set out by the Evidence-based Network for the Interpretation of Germline Mutant Alleles (ENIGMA) consortium for the BRCA1/BRCA2 genes. We also observed that the addition of only few clinical data was sufficient to obtain a more stable classification for variants considered as “likely pathogenic” or “likely non pathogenic”. This shows the importance of obtaining as many as possible points of evidence for variant interpretation, especially from the clinical setting.

(Canada) Analysis - DNA Mismatch Repair Deficiency Tumour Testing for Patients With Colorectal Cancer: Ethical Issues (eg. equity?)

 Blogger's Note: a second book (analysis of issues)

open access - NCBI Bookshelf

Show details

CADTH Optimal Use Report, No. 5.3c.

Duthie K, Bond K, Kaunelis D.

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Aug.

• Contents

 Distributing the benefits and burdens fairly (equity)

Another consideration for the implementation of universal dMMR tumour testing for both treatment optimization and LS diagnosis is whether access to the necessary expertise and services is fairly distributed among the affected population regardless of income level, education, or cultural background. If it is found that the current system favours access only for those of a particular group (especially a privileged group) and that this injustice cannot be rectified, decision-makers would need to think carefully about implementing such a program.

Don't tell cancer patients what they could be doing to cure themselves Opinion

Opinion | The Guardian
 

Comments

791

If you’re a religious person, for the love of God, don’t tell someone with cancer that if they’d just drink juice (or take vitamins, or pray or have a “positive attitude”) that they could cure themselves.
And if you’re not a religious person, for the love of reason and decency, don’t tell someone with cancer any of these things, either......

 Over the years, it was painful for me to see people tell my sister (and me) that she could just cure herself if she really wanted to.

(U.S.) Recalls, Market Withdrawals: Levsin (hyoscyamine) sulfate

Recalls, Market Withdrawals
 Sept 14, 2016

Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results

(Lynch) Mismatch Repair Polymorphisms as Markers of Breast Cancer Prevalence in the (NY) Breast Cancer Family Registry

abstract

Background: Major breast cancer susceptibility genes involved in DNA repair, including BRCA1 and BRCA2, have been identified. However, mutations in these genes account for only 5-10% of identified breast cancer cases. Additional DNA repair pathway genes may also contribute to susceptibility.

Materials and Methods: We investigated the association between 12 single nucleotide polymorphisms (SNPs) in mismatch repair (MMR) genes and breast cancer risk among 313 sister-sets enrolled in the New York site of the Breast Cancer Family Registry (BCFR) (n=744) using conditional logistic regression analysis.

Results: An increase in breast cancer risk was observed for women with the MUTYH_rs3219489 variant allele (odds ratio (OR)=2.23, 95% confidence interval (CI)=1.10-4.52) and for women with the MSH2_rs2303428 variant allele (OR=1.73, 95% CI=1.00-2.99).

Conclusion: Deficiencies in DNA repair pathways, such as MMR, have implications for the onset of familial breast cancer.

AllTrials – UN calls for global action on clinical trial transparency

AllTrials

 In a landmark report released today, the United Nations called on governments worldwide to pass legislation requiring clinical trials to be registered, and their methods and results to be fully reported. The report, authored by a high-level panel appointed by UN Secretary General Ban Ki-moon, explicitly calls for clinical trial study designs, protocols, data sets, and test results to be made publicly available.....

Stage IV Uterine Cancer & BRCA Gene Mutation Story Gets Interesting

Stage IV Uterine Cancer

 Epigenetic modifications functionally silence normal genes leaving patients with the equivalent of an absent gene.

Health concerns over talc continue as U.S. courts sift through evidence - legal/opinion

Legal Examiner Voices

Expert Sheds Light on Important Variables in Preventive Surgery in Ovarian Cancer

Markman interview

 Secondly, surgical menopause is a concern.

A Prospective Evaluation of Early Detection Biomarkers for Ovarian Cancer in the European EPIC Cohort

Clinical Cancer Research
 

Abstract

Purpose: About 60% of ovarian cancers are diagnosed at late stage, when 5-year survival is less than 30% in contrast to 90% for local disease. This has prompted search for early detection biomarkers. For initial testing, specimens taken months or years before ovarian cancer diagnosis are the best source of information to evaluate early detection biomarkers. Here we evaluate the most promising ovarian cancer screening biomarkers in prospectively collected samples from the European Prospective Investigation into Cancer and Nutrition study.

Experimental Design: We measured CA125, HE4, CA72.4, and CA15.3 in 810 invasive epithelial ovarian cancer cases and 1,939 controls. We calculated the sensitivity at 95% and 98% specificity as well as area under the receiver operator curve (C-statistic) for each marker individually and in combination. In addition, we evaluated marker performance by stage at diagnosis and time between blood draw and diagnosis.

Results: We observed the best discrimination between cases and controls within 6 months of diagnosis for CA125 (C-statistic = 0.92), then HE4 (0.84), CA72.4 (0.77), and CA15.3 (0.73). Marker performance declined with longer time between blood draw and diagnosis and for earlier staged disease. However, assessment of discriminatory ability at early stage was limited by small numbers. Combinations of markers performed modestly, but significantly better than any single marker.

Conclusions: CA125 remains the single best marker for the early detection of invasive epithelial ovarian cancer, but can be slightly improved by combining with other markers. Identifying novel markers for ovarian cancer will require studies including larger numbers of early-stage cases. Clin Cancer Res; 22(18); 4664–75. ©2016 AACR.

See related commentary by Skates, p. 4542

This article is featured in Highlights of This Issue, p. 4537

EPIC Early Detection of Ovarian Cancer

Clinical Cancer Research
 Published 15 September 2016

Abstract

CA125 dominated performance for ovarian cancer early detection among four serum biomarkers evaluated in EPIC study prediagnostic serum, rising on average 3 years prior to detection. Adding HE4 provided only marginal improvement. This natural history supports annual testing for early detection and highlights the importance of biomarker discovery complementing CA125. Clin Cancer Res; 22(18); 4542–4. ©2016 AACR.

See related article by Terry et al., p. 4664

NOCC brochure: Ovarian Cancer Quality of Life Issues

brochure

ROCA: Company Stops Sales Of Ovarian Cancer Screening Test After FDA Warns Women Not To Use It

Forbes
Sep 14, 2016 

 
The manufacturer of an ovarian cancer screening test that was the focus of a Food and Drug Administration “safety communication” last week says it is suspending U.S. sales.
Abcodia, a privately held London-based company with a Boston office, launched the $295 ROCA (“Risk of Ovarian Cancer Algorithm”) test last December in a few states. Eventually, it became available in the District of Columbia and every state except Alaska, Florida, Hawaii and New York. No other test marketed for screening average-risk women for ovarian cancer is currently sold in the United States.
The test uses changes in a woman’s blood levels of CA-125–a protein found in greater amounts in people with ovarian and other cancers–as well as whether she’s postmenopausal or has ovarian cancer risk factors to estimate her odds of being diagnosed with the disease. Doctors already use CA-125 to check for recurrences in ovarian cancer patients, but the protein can be elevated for reasons other than cancer, leading to false positives when used to screen average-risk, apparently healthy women for early tumors......

B.C. medicare case argues for wrong prescription (Day vs Canadian medicare)

media - commentary

 Since the inception of medicare in Canada, opinion polls in all parts of the country consistently show a vast majority of Canadians believe in equal access to health care based on need, not ability to pay.

Science News Service Hacked, Taken Offline (Sept 14th)

Science News Service Hacked, Taken Offline

Aug 2016: CADTH - DNA Mismatch Repair Deficiency Tumour Testing for Patients With Colorectal Cancer: A Health Technology Assessment

open access (337 pages)

Cite as: DNA mismatch repair deficiency tumour testing for patients with colorectal cancer: a health technology assessment. Ottawa: CADTH; 2016 Aug. (CADTH optimal use report; vol.5, no.3b).
 

trailer: Pink & Blue: Colors of Hereditary Cancer

Tugg

Synopsis: An emotional journey that takes us through the lives of women — and men — who are dealing with genetic mutations (BRCA 1, BRCA 2) plus their BRCA related cancers.  We meet doctors and their patients who make tough decisions about whether to have preventative surgeries or not.  Director Alan M. Blassberg tells the story of how hereditary cancer has ripped his family apart and what he must face as a BRCA 2 positive male.  The film highlights the message that men have the same 50/50 chance of inheriting a BRCA mutation as a woman and the lack of this information is deadly.  A higher percentage of men who have breast cancer die from it than women.  Dr. Kristi Funk, Angelina Jolie’s breast surgeon, speaks passionately about the need for awareness and thus, prevention.  We also meet those who ultimately don't survive but speak with the hope that their passing will help save the lives of others 

The funny side of cancer: MD’s book based on belief laughter can help patients better endure disease

media

 Now, to press home his case about the funny side of malignancy, he’s published a book of cartoons that illustrate some of the comical interactions he’s had with cancer patients.

Enforcing Reproducibility Improves the Accuracy of Scientific Predictions

 September 13, 2016

It may be time to hold scientific meetings dedicated to reproducibility issues in research, according to Daniel J. Drucker, MD, PhD, senior scientist at the Lunenfeld Tanenbaum Research Institute at Mt. Sinai Hospital, and a professor of medicine at the University of Toronto in Canada. In a recent article, Dr Drucker cites the chasm between biomedical scientists' astounding preclinical success and meager clinical translatability.¹ According to Dr Drucker, researchers should apply the rules used for clinical trials to preclinical research.
“We are bombarded daily with amazing scientific advances, often in preclinical studies, which regularly promise a cure for a disease or a game changer in approach to treatment. The reality is more sobering,” Dr Drucker told Cancer Therapy Advisor......

 Dr Drucker proposes having reproducibility symposia, and testing hypotheses in more than 1 animal model, before making a splash over a potential scientific advance. His students and postdocs are required to replicate the effects of a potential therapeutic in several animal models before exploring the potential mechanism in tissue and cell cultures. This can prevent underdeveloped conclusions that lead to false hopes among clinicians and their patients.

Controlled studies needed to clarify aspirin’s role in cancer prevention (confirmed GI/Lynch Syndrome)

article

 Results suggested no protective benefit for aspirin therapy against nongastrointestinal cancers.

Anti-tumor immunity identified with new ovarian cancer treatment strategy

medical news

"We wanted to explore anti-PD-L1 therapies specifically for ovarian cancer, but we also wanted to determine if other drugs that did not cause these negative anti-PD-L1 antibody-related side effects could be used to target this cancer-promoting pathway," said Rugang Zhang, Ph.D., professor and co-program leader in the Gene Expression and Regulation program at The Wistar Institute and lead author of the study.

More information: Cell Reports, DOI: 10.1016/j.celrep.2016.08.032

Journal reference: Cell Reports

(Seattle) Delmar Pharma (DMPI) Announces Presentation of Positive VAL-083 Data as Ovarian Cancer Treatment

financial news

DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) announced that the Company and its collaborators from the University of Texas MD Anderson Cancer Center presented new data in a research poster entitled "Activity of dianhydrogalactitol (VAL-083) in ovarian tumor models, sensitive or resistant to cisplatin" at the 11th Biennial Ovarian Cancer Research Symposium.
The data, presented on the evening of Monday, September 12th at the Rivkin Center for Ovarian Cancer in Seattle, Washington, support a distinct mechanism of action for VAL-083 versus platinum-based chemotherapy currently used in the treatment of ovarian cancer.....

Siamab Therapeutics Presents Promising Preclinical Data at 2016 AACR Ovarian Cancer Research Symposium (Seattle)

financial news

Siamab Therapeutics, Inc., a biotechnology company developing novel cancer immunotherapies, today announced new pre-clinical data that showed its novel ST1 antibody drug conjugates (ADCs) target chemoresistant ovarian cancer cells and demonstrate strong efficacy in ovarian cancer models. These data were presented at the American Association for Cancer Research (AACR)’s 11th Biennial Ovarian Cancer Research Symposium 2016 in Seattle, Wash., on Monday, Sept. 12, 2016.

Siamab’s ST1 ADCs target the cancer associated antigen, sialyl-Tn (STn) with high specificity and affinity. STn is present on multiple solid tumors including ovarian, pancreatic, prostate and colon, while showing little normal tissue expression, and has been implicated in immune suppression, metastasis, and a cancer stem cell phenotype.

“The preclinical results are exciting and show the potential of our antibody approach to target chemoresistant tumors in ovarian cancer,” said Jeff Behrens, president and chief executive officer of Siamab Therapeutics. “We have developed multiple anti-glycan antibodies and ADCs with unprecedented cancer specificity and efficacy in animal models. These findings hold promise for developing new cancer therapeutics for ovarian cancer patients with disease recurrence who have limited treatment options.”

The preclinical data were presented in a poster titled “Targeting a chemoresistant ovarian cancer cell population via the carbohydrate antigen sialyl Tn.” The findings showed that Siamab’s ST1 ADCs significantly reduce tumor volume in a sustained fashion in ovarian cancer models.....

infograph: Anticancer chemotherapy in teenagers/young adults: managing long term side effects

The BMJ (open access)

Cite this as: BMJ 2016;354:i4567

Infographic available

Click here for a visual overview of long term side effects, including principal causitive drugs, risk factors and management of those at risk.

Sleep Duration and Cancer in the NIH-AARP Diet and Health Study Cohort

open access

Background

Very few studies have examined sleep duration in relation to cancer incidence with the exception of breast cancer.

Methods

We assessed the associations between sleep duration and incidences of total and 18 site-specific cancers in the NIH-AARP Health and Diet Study cohort, with 173,327 men and 123,858 women aged 51–72 years at baseline. Self-reported sleep duration categories were assessed via questionnaire. We used multivariable Cox proportional hazards regression to estimate hazard ratios (HR) and 95% confidence intervals (CI), using 7–8 hours/night as the reference.

 A decreased ovarian cancer risk _{≥ 9 vs. 7–8 hours}

Study population

The NIH-AARP Diet and Health Study, described in detail previously [23], was established in 1995–1996 to evaluate association of diet and health. A total of 567,169 of 3.5 million members of AARP (formerly known as the American Association of Retired Persons), aged 50–71, completed baseline questionnaires, who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan).....

 Incident cancer cases were invasive and consisted only of the first malignant neoplasm diagnosed during the follow-up period if multiple cancers had been diagnosed in the same participant....

 Sensitivity analyses by removing physical activity, sedentary behavior, BMI, diabetes, hypertension, or any dietary variables did not change our results and conclusion (S1 Table). Removing cancers diagnosed within the first two years of follow-up did not change our observation materially (S2 Table).