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Collecting Tumor Samples From Patients With Gynecological Tumors

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00897442
First received: May 9, 2009
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Borderline Ovarian Clear Cell Tumor
Borderline Ovarian Serous Tumor
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Childhood Embryonal Rhabdomyosarcoma
Childhood Malignant Ovarian Germ Cell Tumor
Endometrioid Stromal Sarcoma
Gestational Trophoblastic Tumor
Malignant Mesothelioma
Malignant Ovarian Epithelial Tumor
Melanoma
Neoplasm of Uncertain Malignant Potential
Ovarian Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Paget Disease of the Vulva
Recurrent Cervical Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Ovarian Germ Cell Tumor
Recurrent Primary Peritoneal Carcinoma
Recurrent Uterine Corpus Carcinoma
Recurrent Vaginal Carcinoma
Recurrent Vulvar Carcinoma
Stage I Ovarian Cancer
Stage I Uterine Corpus Cancer
Stage I Vaginal Cancer
Stage I Vulvar Cancer
Stage IA Cervical Cancer
Stage IA Fallopian Tube Cancer
Stage IA Ovarian Cancer
Stage IA Ovarian Germ Cell Tumor
Stage IB Cervical Cancer
Stage IB Fallopian Tube Cancer
Stage IB Ovarian Cancer
Stage IB Ovarian Germ Cell Tumor
Stage IC Fallopian Tube Cancer
Stage IC Ovarian Cancer
Stage IC Ovarian Germ Cell Tumor
Stage II Ovarian Cancer
Stage II Uterine Corpus Cancer
Stage II Vaginal Cancer
Stage II Vulvar Cancer
Stage IIA Cervical Cancer
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Cancer
Stage IIA Ovarian Germ Cell Tumor
Stage IIB Cervical Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Cancer
Stage IIB Ovarian Germ Cell Tumor
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Cancer
Stage IIC Ovarian Germ Cell Tumor
Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor
Stage III Cervical Cancer
Stage III Uterine Corpus Cancer
Stage III Vaginal Cancer
Stage III Vulvar Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Ovarian Germ Cell Tumor
Stage IIIC Primary Peritoneal Cancer
Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Stage IV Uterine Corpus Cancer
Stage IVA Cervical Cancer
Stage IVA Vaginal Cancer
Stage IVB Cervical Cancer
Stage IVB Vaginal Cancer
Stage IVB Vulvar Cancer
Uterine Corpus Cancer
Uterine Corpus Leiomyosarcoma
Vulvar Squamous Cell Carcinoma
Other: Laboratory Biomarker Analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Collection of gynecological tumor specimens and serum from patients at GOG institutions [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Create a repository for long-term storage of these specimens [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Make available tissue and blood for proposed projects [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Tumor Samples

Enrollment: 275
Study Start Date: June 1992
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (biomarker sampling and analysis)
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.
Other: Laboratory Biomarker Analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Gynecological Tumors
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)
        • 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
  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 187 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Cibull NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00897442     History of Changes
Other Study ID Numbers: GOG-0136  NCI-2009-00577  GOG-136  CDR0000078647  GOG-0136  GOG-0136  U10CA180868 
Study First Received: May 9, 2009
Last Updated: October 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mesothelioma
Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Ovarian Neoplasms
Uterine Cervical Neoplasms
Neoplasms, Germ Cell and Embryonal
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Rhabdomyosarcoma
Germinoma
Leiomyosarcoma
Vulvar Neoplasms
Vaginal Neoplasms
Cystadenocarcinoma, Serous
Carcinoma, Adenosquamous
Brenner Tumor
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Trophoblastic Neoplasms
Cystadenocarcinoma
Uterine Neoplasms
Rhabdomyosarcoma, Embryonal
Sarcoma, Endometrial Stromal
Gestational Trophoblastic Disease
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on December 09, 2016