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Collecting Tumor Samples From Patients With Gynecological Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00897442
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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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.

Condition or disease Intervention/treatment
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

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 Design
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Study Type : Observational
Actual Enrollment : 275 participants
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
Study Start Date : June 1992
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Collection of gynecological tumor specimens and serum from patients at GOG institutions [ Time Frame: Baseline ]
  2. Create a repository for long-term storage of these specimens [ Time Frame: Baseline ]
  3. Make available tissue and blood for proposed projects [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
Tumor Samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897442


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Michael Cibull NRG Oncology
More Information
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Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00897442    
Other Study ID Numbers: GOG-0136
NCI-2009-00577 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-136
CDR0000078647
GOG-0136 ( Other Identifier: NRG Oncology )
GOG-0136 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Mesothelioma
Mesothelioma, Malignant
Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Uterine Cervical Neoplasms
Neoplasms, Germ Cell and Embryonal
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Rhabdomyosarcoma
Germinoma
Leiomyosarcoma
Vulvar Neoplasms
 Vaginal Neoplasms
Cystadenocarcinoma
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Trophoblastic Neoplasms
Carcinoma, Adenosquamous
Cystadenocarcinoma, Serous
Brenner Tumor
Sarcoma, Endometrial Stromal
Rhabdomyosarcoma, Embryonal
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes