Collecting Tumor Samples From Patients With Gynecological Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897442
First received: May 9, 2009
Last updated: August 30, 2012
Last verified: December 2011
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897442

  Show 125 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Michael L. Cibull, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Additional Information:
Publications:
Havrilesky LJ, Alvarez AA, Whitaker R, et al.: Loss of expression of the P16 tumor suppressor gene is more frequent in advanced ovarian cancers lacking P53 mutations. [Abstract] Society of Gynecologic Oncologists 2004 Annual Meeting on Women's Cancer, 7-11 February 2004, San Diego, California. A-814, 2004.

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):
cervical small cell carcinoma
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 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
uterine leiomyosarcoma
endometrial stromal sarcoma
neoplasm of uncertain malignant potential
melanoma
embryonal childhood rhabdomyosarcoma
Paget disease of the vulva

ClinicalTrials.gov processed this record on September 18, 2014