Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer
Recruitment status was Not yet recruiting
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Purpose
RATIONALE: 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.
PURPOSE: This research study is studying racial and genetic biomarkers of response in tissue samples from patients with endometrial cancer.
| Condition | Intervention |
|---|---|
|
Endometrial Cancer |
Genetic: gene expression analysis Other: laboratory biomarker analysis Other: medical chart review Other: study of socioeconomic and demographic variables |
| Study Type: | Observational |
| Official Title: | The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes |
- Proportion of genetic background that is of African-American descent [ Designated as safety issue: No ]
- Progression-free survival and overall survival [ Designated as safety issue: No ]
- Clinicopathologic and demographic characteristics [ Designated as safety issue: No ]
| Estimated Enrollment: | 243 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To identify racial categorization as the proportion of genetic background of African-American or European-American women with endometrioid endometrial cancer (EEC).
- To evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes.
Secondary
- To compare the concordance between racial genetic admixture and self-designated race categorization.
OUTLINE: This is a multicenter study. Patients are stratified by race (African-American vs European-American) and disease stage (I vs II vs III vs IV).
DNA from archived frozen normal tissue samples are genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
- Consented their specimens and clinical data to be collected and used in future studies
- Self-declared African-American or Caucasian race
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01198171 History of Changes |
| Other Study ID Numbers: | CDR0000684547, GOG-8022 |
| Study First Received: | September 8, 2010 |
| Last Updated: | September 8, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 19, 2013