Clinical trial NCT01198171: Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer
Official title: The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage I Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-09-09
Enrollment: 243
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with endometrial cancer

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.

Detailed description: PRIMARY OBJECTIVES:

I. To identify racial categorization as the proportion of genetic background of African-American or European-American women with endometrioid endometrial cancer (EEC).

II. To evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes.

SECONDARY OBJECTIVES:

I. 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 is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: Proportion of genetic background that is of African-American descent
timeFrame: 1 year
Secondary outcomes:
measure: Racial genetic admixture score, summarized by race and other clinicopathologic variables
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Rodney Rocconi
role: PRINCIPAL_INVESTIGATOR
References: