Endometrial Serous Adenocarcinoma Clinical Trial
Official title:
The Role of Synuclein-gamma (SNCG) in the Carcinogenesis of Uterine Papillary Serous Carcinoma
Verified date | May 2015 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This research study is studying biomarkers in blood and tissue samples from patients with uterine cancer. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.
Status | Not yet recruiting |
Enrollment | 360 |
Est. completion date | |
Est. primary completion date | January 2100 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women with uterine papillary serous carcinoma (UPSC) who were eligible for GOG-0210 protocol, a molecular staging study in endometrial cancer, or GOG-0136, a general specimen banking study for gynecologic cancer, have consented to future research, have histologically-confirmed UPSC of any stage, and have satisfactory formalin-fixed and paraffin-embedded primary tumor with or without a satisfactory pre-operative serum specimen available for testing - Women with endometrioid endometrial cancer who were eligible for GOG-0210 or GOG-0136, have consented to future research, have histologically-confirmed endometrioid endometrial carcinoma with a similar stage, age and race/ethnicity distribution as the UPSC patients, have satisfactory formalin-fixed and paraffin-embedded primary tumor and/or pre-operative serum specimen available for testing - Normal healthy control women who participated in the Biopathology protocol for banking sera from normal healthy control women, have consented to future research, do not have a cancer or a history of cancer and have a similar age and race/ethnicity distribution as the UPSC patients and have satisfactory serum available for testing |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Kaplan-Meier survival curves for the overall survival (OS) endpoint will be generated separately for the three SNCG expression groups and globally compared using a log-rank test. | From time of entry onto GOG-0210, assessed up to 2 years | No |
Secondary | Presence of synchronous or metachronous breast cancer | Cox proportional hazards models with dummy variable coding of the SNCG expression groups will be used to estimate hazard ratios, with tests of interaction with time and log-log plots used to evaluate the proportional hazards assumption. Sensitivity of the estimated hazard ratios to adjustment for other variables will be explored in the analyses for the Secondary Objectives. | Up to 2 years | No |
Secondary | Progression-free survival | Median survival times and 95% confidence intervals will be estimated from the Kaplan-Meier curves using Greenwood's formula for variance estimation. | From time of entry onto GOG-0210 to time of progression, assessed up to 2 years | No |
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