ClinicalTrials.gg
CompletedNCT00897442Updated Oct 28, 2016

Collecting Tumor Samples From Patients With Gynecological Tumors

An observational study in Borderline Ovarian Clear Cell Tumor, Borderline Ovarian Serous Tumor and Cervical Adenocarcinoma, sponsored by Gynecologic Oncology Group. Completed at 187 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Gynecologic Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
275
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Ovarian Germ Cell Cancer

30 studies on the registry are indexed under Ovarian Germ Cell Cancer; 2 are open to participants now.

Browse Ovarian Germ Cell Cancer studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients With Gynecological Tumors

Eligibility 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
275 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  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

07

Study locations

187 sites
  • Highlands Oncology Group PA - Fayetteville
    Fayetteville, Arkansas 72703, United States
  • Washington Regional Medical Center - Fayetteville
    Fayetteville, Arkansas 72703, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Long Beach Memorial Medical Center-Todd Cancer Institute
    Long Beach, California 90806, United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • Stanford Cancer Institute
    Palo Alto, California 94304, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California 94115, United States
  • Olive View-University of California Los Angeles Medical Center
    Sylmar, California 91342, United States
  • Colorado Gynecologic Oncology Group
    Aurora, Colorado 80010, United States
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
    Aurora, Colorado 80045, United States
  • Danbury Hospital
    Danbury, Connecticut 06810, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • MedStar Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Sibley Memorial Hospital
    Washington, District of Columbia 20016, United States
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Florida Gynecologic Oncology
    Fort Myers, Florida 33905, United States
  • Jupiter Medical Center
    Jupiter, Florida 33458, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida 33136, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Augusta University Medical Center
    Augusta, Georgia 30912, United States
  • Northeast Georgia Medical Center
    Gainesville, Georgia 30501, United States
  • Memorial University Medical Center
    Savannah, Georgia 31404, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453-2699, United States
  • Memorial Medical Center
    Springfield, Illinois 62781, United States
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Saint Vincent Hospital and Health Care Center
    Indianapolis, Indiana 46260, United States
  • Northern Indiana Cancer Research Consortium
    South Bend, Indiana 46628, United States
  • Medical Oncology and Hematology Associates-West Des Moines
    Clive, Iowa 50325, United States
  • Mercy Cancer Center-West Lakes
    Clive, Iowa 50325, United States
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Iowa-Wide Oncology Research Coalition NCORP
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates-Des Moines
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates-Laurel
    Des Moines, Iowa 50314, United States
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
  • Methodist West Hospital
    West Des Moines, Iowa 50266-7700, United States
  • Mercy Medical Center-West Lakes
    West Des Moines, Iowa 50266, United States
  • Our Lady Bellefonte Hospital
    Ashland, Kentucky 41101, United States
  • Saint Elizabeth Medical Center South
    Edgewood, Kentucky 41017, United States
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
  • Norton Hospital Pavilion and Medical Campus
    Louisville, Kentucky 40202, United States
  • Woman's Hospital
    Baton Rouge, Louisiana 70817, United States
  • Tulane University Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • CHRISTUS Highland Medical Center
    Shreveport, Louisiana 71105, United States
  • Maine Medical Center-Bramhall Campus
    Portland, Maine 04102, United States
  • The Union Memorial Hospital
    Baltimore, Maryland 21218, United States
  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
    Baltimore, Maryland 21237, United States
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889-5600, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • University of Massachusetts Memorial Health Care
    Worcester, Massachusetts 01605, United States
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Hurley Medical Center
    Flint, Michigan 48502, United States
  • Gynecologic Oncology of West Michigan PLLC
    Grand Rapids, Michigan 49546, United States
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Saint Dominic-Jackson Memorial Hospital
    Jackson, Mississippi 39216, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Keesler Medical Center
    Kessler AFB, Mississippi 39534, United States
  • University of Missouri - Ellis Fischel
    Columbia, Missouri 65212, United States
  • Saint Louis University Hospital
    Saint Louis, Missouri 63110, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Cancer Research for the Ozarks NCORP
    Springfield, Missouri 65804, United States
  • Mercy Hospital Springfield
    Springfield, Missouri 65804, United States
  • CoxHealth South Hospital
    Springfield, Missouri 65807, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Sunrise Hospital and Medical Center
    Las Vegas, Nevada 89109, United States
  • Women's Cancer Center of Nevada
    Las Vegas, Nevada 89169, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Cooper Hospital University Medical Center
    Camden, New Jersey 08103, United States
  • Hackensack University Medical CCOP
    Hackensack, New Jersey 07601, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Rutgers New Jersey Medical School
    Newark, New Jersey 07101, United States
  • University of New Mexico Cancer Center
    Albuquerque, New Mexico 87102, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Winthrop University Hospital
    Mineola, New York 11501, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Columbia University/Herbert Irving Cancer Center
    New York, New York 10032, United States
  • Stony Brook University Medical Center
    Stony Brook, New York 11794, United States
  • UNC Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina 27599, United States
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina 28203, United States
  • Novant Health Presbyterian Medical Center
    Charlotte, North Carolina 28204, United States
  • Gynecologic Oncology Network
    Greenville, North Carolina 27834, United States
  • Pitt County Memorial Hosp Inc.
    Greenville, North Carolina 27834, United States
  • East Carolina University
    Greenville, North Carolina 27858, United States
  • FirstHealth of the Carolinas-Moore Regional Hosiptal
    Pinehurst, North Carolina 28374, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Akron General Medical Center
    Akron, Ohio 44307, United States
  • Good Samaritan Hospital - Cincinnati
    Cincinnati, Ohio 45220, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States

Showing the first 100 of 187 sites. Choose a country and city above to see the rest.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 1992 and a primary completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2009
First posted
May 12, 2009
Start
Jun 1992
Primary completionActual
Jan 2016
Last update
Oct 28, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00897442
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jun 1992
Primary completion
Jan 2016
Last update
Oct 28, 2016

Study contacts

Michael Cibull
principal investigator · NRG Oncology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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