Collecting Tumor Samples From Patients With Gynecological Tumors

Completed

• Conditions: Cervical Small Cell Carcinoma; Endometrioid Stromal Sarcoma; Ovarian Serous Cystadenocarcinoma; Recurrent Cervical Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Germ Cell Tumor; Recurrent Uterine Corpus Carcinoma; Recurrent Vaginal Carcinoma; Recurrent Vulvar Carcinoma; Stage I Ovarian Cancer

• Registration Number: NCT00897442
• Lead Sponsor: Gynecologic Oncology Group

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.

Study Timeline

• Study Start: 1992-06
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2016-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 275

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)
      • Patients with a rare gynecologic malignancy of the peritoneum, including primary peritoneal cancer or mesothelioma
      • Patients with carcinoma of the fallopian tube
      • Patients with a rare gynecologic malignancy of the cervix including verrucous, small cell, clear cell, serous, or adenoid cystic carcinomas; carcinoid tumors; malignant mixed mesodermal tumors; or leiomyosarcoma
      • Patients with a rare gynecologic malignancy of the uterine corpus including leiomyosarcoma; malignant mixed mesodermal tumors; endometrial stromal sarcomas; smooth muscle tumors of unknown malignant potential; or clear cell or small cell carcinomas
      • Patients with a rare gynecologic malignancy of the vagina including verrucous or clear cell carcinomas; melanoma; embryonal rhabdomyosarcoma; or endodermal sinus tumor
      • Patients with a rare gynecologic malignancy of the vulva including verrucous carcinoma; melanoma; aggressive angiomyxoma; sarcoma; malignant Paget's disease; or Bartholin gland carcinoma
      • Patients with a gestational trophoblastic tumor
      • Patients with a tumor arising in endometriosis

    • Group C: Women who underwent prophylactic oophorectomy and have at least 1 gram of ovarian tissue and blood available for submission for this protocol

    • Group D: Women who underwent surgery to monitor or treat a persistent or recurrent gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, and have persistent or recurrent tumor, normal tissue, and blood available for submission for this protocol

• Concurrent primary cancers are allowed

• No benign cystic tumors of the ovary, including cystic epithelial tumors and mature cystic teratomas

• Prior cytotoxic chemotherapy allowed

• Prior hormonal therapy allowed

• Prior radiotherapy allowed

• Prior surgery allowed

• No more than 6 weeks after prior surgery

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Create a repository for long-term storage of these specimens	Baseline
Make available tissue and blood for proposed projects	Baseline
Collection of gynecological tumor specimens and serum from patients at GOG institutions	Baseline

Trial Locations

Locations (187)

Highlands Oncology Group PA - Fayetteville; 🇺🇸 Fayetteville, Arkansas, United States

Washington Regional Medical Center - Fayetteville; 🇺🇸 Fayetteville, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center; 🇺🇸 Burbank, California, United States

Long Beach Memorial Medical Center-Todd Cancer Institute; 🇺🇸 Long Beach, California, United States

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Stanford Cancer Institute; 🇺🇸 Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

UCSF Medical Center-Mount Zion; 🇺🇸 San Francisco, California, United States

Scroll for more (177 remaining)