Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01198171
First received: September 8, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of genetic background that is of African-American descent [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198171

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Rodney P. Rocconi, MD University of South Alabama Mitchell Cancer Institute
  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
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014