Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer

Gynecologic Oncology Group187 sites in 1 country275 target enrollmentJune 1992

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Borderline Ovarian Clear Cell Tumor
Sponsor: Gynecologic Oncology Group
Enrollment: 275
Locations: 187
Primary Endpoint: Create a repository for long-term storage of these specimens
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To collect gynecologic tissue and blood from participating Gynecologic Oncology Group (GOG) institutions. II. To provide a repository for long-term storage of gynecologic tissue and blood that will be used in studies designed to better understand the molecular biology of gynecologic tumors. III. To make available, through the GOG Tissue Bank, tissue and blood for proposed projects conducted by GOG and non-GOG investigators. OUTLINE: Snap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues.

Registry

clinicaltrials.gov

Start Date

June 1992

End Date

January 2016

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Gynecologic Oncology Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any of the following:
•Patients who have had gynecologic tissue removed during surgery to diagnosis, treat, monitor, and/or prevent primary, persistent, or recurrent gynecologic cancer of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, meeting at least one of the following criteria:
•Group A: Women who underwent surgery, were diagnosed with a primary gynecologic malignancy of the ovary, cervix, uterine corpus, or vulva, and have primary tumor, normal tissue, and blood available for submission for this protocol
•Patients with ovarian cancer including all stages, grades, and common epithelial cell types
•Invasive cancers and serous and mucinous borderline tumors of low malignant potential are allowed
•At least 1 gram of frozen primary tumor tissue must be submitted for this protocol for patients with FIGO stage III or IV epithelial ovarian cancer
•Patients with an invasive malignancy of the cervix or uterine corpus including all stages, grades, and common cell types
•Patients with squamous cell carcinoma of the vulva
•Group B: Women who underwent surgery and were diagnosed with a rare gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, vulva, a gestational trophoblastic tumor, or a tumor arising in endometriosis, and have tumor tissue available for submission for this protocol
•Patients with a rare gynecologic malignancy of the ovary including malignant germ cell tumors; sex cord-stromal tumors; malignant mixed mesodermal tumors; clear cell, mucinous, small cell, or transitional cell carcinomas; malignant Brenner tumors; or borderline tumors of low malignant potential (except serous and mucinous)