Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer
The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes
8 other identifiers
observational
243
1 country
1
Brief Summary
This research study is studying racial and genetic biomarkers of response in tissue samples from patients with endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 14, 2024
August 1, 2024
7.1 years
September 8, 2010
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Clinicopathologic and demographic characteristics: characteristics: self-reported race, stage, age, race, parity, body-mass index, stage, grade, depth of invasion, lymph-vascular space invasion, and metastasis
1 year
Overall survival
1 year
Progression-free survival
1 year
Proportion of genetic background that is of African-American descent
1 year
Secondary Outcomes (1)
Racial genetic admixture score, summarized by race and other clinicopathologic variables
1 year
Study Arms (1)
Basic science (DNA analysis)
DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.
Interventions
Eligibility Criteria
Patient with endometrial cancer
You may qualify if:
- Histologically confirmed endometrial cancer
- Stage I-IV disease regardless of grade
- Underwent surgical staging including hysterectomy, bilateral oophorectomy, washings, and pelvic lymphadenectomy
- Eligible and evaluated on GOG-0210 clinical trial, a Molecular Staging Study in Endometrial Cancer
- Available frozen or formalin-fixed and paraffin-embedded normal tissue that is free of tumor cells and yields sufficient high-quality normal DNA for testing
- Consented their specimens and clinical data to be collected and used in future studies
- Self-declared African-American or Caucasian race
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Rodney Rocconi
Gynecologic Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 9, 2010
Study Start
January 1, 2010
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
August 14, 2024
Record last verified: 2024-08