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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

May 9, 2009
October 26, 2016
June 1992
January 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00897442 on ClinicalTrials.gov Archive Site
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Collecting Tumor Samples From Patients With Gynecological Tumors
Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Tumor Samples
Non-Probability Sample
Patients With Gynecological Tumors
  • 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
Correlative studies
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.
Intervention: Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
Not Provided
January 2016   (final data collection date for primary outcome measure)

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
Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897442
GOG-0136, NCI-2009-00577, GOG-136, CDR0000078647, GOG-0136, GOG-0136, U10CA180868
Not Provided
Not Provided
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Michael Cibull NRG Oncology
Gynecologic Oncology Group
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP