Status:
COMPLETED
Collecting Tumor Samples From Patients With Gynecological Tumors
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Borderline Ovarian Clear Cell Tumor
Borderline Ovarian Serous Tumor
Eligibility:
FEMALE
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...
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 tiss...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 1 1992
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00897442
Start Date
June 1 1992
Last Update
October 28 2016
Active Locations (187)
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1
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, United States, 72703
2
Washington Regional Medical Center - Fayetteville
Fayetteville, Arkansas, United States, 72703
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505