Collecting Tumor Samples From Patients With Gynecological Tumors

Melanoma Clinical Trial

Official title:

Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897442
• Other study ID #: GOG-0136
• Secondary ID: NCI-2009-00577GO
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: October 26, 2016
• Start date: June 1992

Study information

• Verified date: October 2016
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Borderline Ovarian Clear Cell Tumor
• Borderline Ovarian Serous Tumor
• Brenner Tumor
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Small Cell
• Carcinoma, Squamous Cell
• 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
• Cystadenocarcinoma
• Endometrioid Stromal Sarcoma
• Fallopian Tube Neoplasms
• Germinoma
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Leiomyosarcoma
• Lung Neoplasms
• Malignant Mesothelioma
• Malignant Ovarian Epithelial Tumor
• Melanoma
• Mesothelioma
• Neoplasm of Uncertain Malignant Potential
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Ovarian Brenner Tumor
• Ovarian Clear Cell Cystadenocarcinoma
• Ovarian Neoplasms
• Ovarian Serous Cystadenocarcinoma
• Paget Disease of the Vulva
• Peritoneal Neoplasms
• 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
• Rhabdomyosarcoma
• Small Cell Lung 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
• Trophoblastic Neoplasms
• Uterine Cervical Neoplasms
• Uterine Corpus Cancer
• Uterine Corpus Leiomyosarcoma
• Uterine Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms
• Vulvar Squamous Cell Carcinoma

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron General Medical Center	Akron	Ohio
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania
United States	The Don and Sybil Harrington Cancer Center	Amarillo	Texas
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Our Lady Bellefonte Hospital	Ashland	Kentucky
United States	Northside Hospital	Atlanta	Georgia
United States	MultiCare Auburn Medical Center	Auburn	Washington
United States	Augusta University Medical Center	Augusta	Georgia
United States	Colorado Gynecologic Oncology Group	Aurora	Colorado
United States	University of Colorado Cancer Center - Anschutz Cancer Pavilion	Aurora	Colorado
United States	University Medical Center Brackenridge	Austin	Texas
United States	MedStar Franklin Square Medical Center/Weinberg Cancer Institute	Baltimore	Maryland
United States	The Union Memorial Hospital	Baltimore	Maryland
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Saint Luke's University Hospital-Bethlehem Campus	Bethlehem	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California
United States	Cooper Hospital University Medical Center	Camden	New Jersey
United States	Providence Regional Cancer System-Centralia	Centralia	Washington
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Chattanooga's Program in Women's Oncology	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin
United States	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa
United States	Mercy Cancer Center-West Lakes	Clive	Iowa
United States	University of Missouri - Ellis Fischel	Columbia	Missouri
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Clements University Hospital	Dallas	Texas
United States	Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Zale Lipshy University Hospital	Dallas	Texas
United States	Danbury Hospital	Danbury	Connecticut
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin
United States	Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Saint Elizabeth Medical Center South	Edgewood	Kentucky
United States	Highlands Oncology Group PA - Fayetteville	Fayetteville	Arkansas
United States	Washington Regional Medical Center - Fayetteville	Fayetteville	Arkansas
United States	Saint Francis Hospital	Federal Way	Washington
United States	Hurley Medical Center	Flint	Michigan
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Florida Gynecologic Oncology	Fort Myers	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	University of Texas Medical Branch	Galveston	Texas
United States	Gynecologic Oncology of West Michigan PLLC	Grand Rapids	Michigan
United States	East Carolina University	Greenville	North Carolina
United States	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina
United States	Gynecologic Oncology Network	Greenville	North Carolina
United States	Pitt County Memorial Hosp Inc.	Greenville	North Carolina
United States	Hackensack University Medical CCOP	Hackensack	New Jersey
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Virginia Oncology Associates-Hampton	Hampton	Virginia
United States	Hartford Hospital	Hartford	Connecticut
United States	The Methodist Hospital System	Houston	Texas
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Saint Dominic-Jackson Memorial Hospital	Jackson	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	East Tennessee State University	Johnson City	Tennessee
United States	Jupiter Medical Center	Jupiter	Florida
United States	Keesler Medical Center	Kessler AFB	Mississippi
United States	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Marshfield Clinic - Ladysmith Center	Ladysmith	Wisconsin
United States	Saint Clare Hospital	Lakewood	Washington
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Long Beach Memorial Medical Center-Todd Cancer Institute	Long Beach	California
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	Norton Hospital Pavilion and Medical Campus	Louisville	Kentucky
United States	Covenant Medical Center-Lakeside	Lubbock	Texas
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Saint Joseph's Hospital	Marshfield	Wisconsin
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Lake University Ireland Cancer Center	Mentor	Ohio
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	Meharry Medical College	Nashville	Tennessee
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Yale University	New Haven	Connecticut
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Columbia University/Herbert Irving Cancer Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Capital Medical Center	Olympia	Washington
United States	Providence - Saint Peter Hospital	Olympia	Washington
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	Stanford Cancer Institute	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	FirstHealth of the Carolinas-Moore Regional Hosiptal	Pinehurst	North Carolina
United States	UPMC-Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	Compass Oncology Rose Quarter	Portland	Oregon
United States	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon
United States	Maine Medical Center-Bramhall Campus	Portland	Maine
United States	Women and Infants Hospital	Providence	Rhode Island
United States	MultiCare Good Samaritan Hospital	Puyallup	Washington
United States	Black Hills Obstetrics and Gynecology	Rapid City	South Dakota
United States	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin
United States	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin
United States	Carilion Clinic Gynecological Oncology	Roanoke	Virginia
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF Medical Center-Mount Zion	San Francisco	California
United States	Memorial University Medical Center	Savannah	Georgia
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Pacific Gynecology Specialists	Seattle	Washington
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Swedish Medical Center-First Hill	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Virginia Mason CCOP	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	CHRISTUS Highland Medical Center	Shreveport	Louisiana
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Sanford Cancer Center-Oncology Clinic	Sioux Falls	South Dakota
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Cancer Research for the Ozarks NCORP	Springfield	Missouri
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Geisinger Medical Group	State College	Pennsylvania
United States	Marshfield Clinic Cancer Care at Saint Michael's Hospital	Stevens Point	Wisconsin
United States	Saint Michael's Hospital	Stevens Point	Wisconsin
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Olive View-University of California Los Angeles Medical Center	Sylmar	California
United States	MultiCare Allenmore Hospital	Tacoma	Washington
United States	Multicare Health System	Tacoma	Washington
United States	MultiCare Tacoma General Hospital	Tacoma	Washington
United States	Northwest Medical Specialties PLLC	Tacoma	Washington
United States	Northwest NCI Community Oncology Research Program	Tacoma	Washington
United States	Saint Joseph Medical Center	Tacoma	Washington
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Cancer Care Associates-Midtown	Tulsa	Oklahoma
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Marshfield Clinic-Wausau Center	Wausau	Wisconsin
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Mercy Medical Center-West Lakes	West Des Moines	Iowa
United States	Methodist West Hospital	West Des Moines	Iowa
United States	Diagnostic and Treatment Center	Weston	Wisconsin
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	University of Massachusetts Medical School	Worcester	Massachusetts
United States	University of Massachusetts Memorial Health Care	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of gynecological tumor specimens and serum from patients at GOG institutions		Baseline	No
Primary	Create a repository for long-term storage of these specimens		Baseline	No
Primary	Make available tissue and blood for proposed projects		Baseline	No