Collecting Tumor Samples From Patients With Gynecological Tumors
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Purpose
RATIONALE: 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.
PURPOSE: This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors.
| Condition | Intervention |
|---|---|
|
Cancer |
Other: biologic sample preservation procedure |
| Study Type: | Observational |
| Official Title: | Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer |
- Collection of gynecological tumor specimens and serum from patients at GOG institutions [ Designated as safety issue: No ]
- Create a repository for long-term storage of these specimens [ Designated as safety issue: No ]
| Study Start Date: | June 1992 |
OBJECTIVES:
- Collect gynecological tumor specimens and blood from patients at GOG institutions.
- Provide a repository for long-term storage of these specimens.
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.
PROJECTED ACCRUAL: Not specified
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS: Not specified
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- Prior cytotoxic chemotherapy allowed
Endocrine therapy:
- Prior hormonal therapy allowed
Radiotherapy:
- Prior radiotherapy allowed
Surgery:
- Prior surgery allowed
- No more than 6 weeks after prior surgery
Contacts and Locations
Show 125 Study Locations| Study Chair: | Michael L. Cibull, MD | Lucille P. Markey Cancer Center at University of Kentucky |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00897442 History of Changes |
| Other Study ID Numbers: | CDR0000078647, GOG-0136 |
| Study First Received: | May 9, 2009 |
| Last Updated: | August 30, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent vaginal cancer stage I vaginal cancer stage II vaginal cancer stage III vaginal cancer stage IVA vaginal cancer stage IVB vaginal cancer childhood malignant ovarian germ cell tumor ovarian serous cystadenocarcinoma ovarian serous cystadenoma with proliferating activity recurrent ovarian germ cell tumor recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer stage III borderline ovarian surface epithelial-stromal tumor stage IV borderline ovarian surface epithelial-stromal tumor uterine corpus cancer |
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical small cell carcinoma cervical squamous cell carcinoma recurrent cervical cancer stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer squamous cell carcinoma of the vulva Brenner tumor malignant mesothelioma |
ClinicalTrials.gov processed this record on May 16, 2013