Collecting Tumor Samples From Patients… | Clinical Trial

Key information

Conditions

Borderline Ovarian Clear Cell Tumor Adenoma Adnexal Diseases Borderline Ovarian Serous Tumor Brenner 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 Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Endometrial Stromal Tumors Endometrioid Stromal Sarcoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gestational Trophoblastic Disease Gestational Trophoblastic Tumor Gonadal Disorders Lung Diseases Lung Neoplasms Malignant Mesothelioma Malignant Ovarian Epithelial Tumor Melanoma Mesothelioma Mesothelioma, Malignant Neoplasm of Uncertain Malignant Potential Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Brenner Tumor Ovarian Clear Cell Cystadenocarcinoma Ovarian Diseases Ovarian Germ Cell Cancer Ovarian Neoplasms Ovarian Serous Cystadenocarcinoma Paget Disease of the Vulva Pleural Neoplasms Pregnancy Complications Pregnancy Complications, Neoplastic 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 Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Sarcoma, Endometrial Stromal Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases 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 Thoracic Neoplasms Trophoblastic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Corpus Cancer Uterine Corpus Leiomyosarcoma Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms Vulvar Squamous Cell Carcinoma

Sex eligibility

Female

Study type

Observational

Primary location

Highlands Oncology Group PA - Fayetteville, Fayetteville, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

Collection of gynecological tumor specimens and serum from patients at GOG institutions

Time frame: Baseline
Create a repository for long-term storage of these specimens

Time frame: Baseline
Make available tissue and blood for proposed projects

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 1992
Primary completion: 2016
First posted: May 12, 2009
Registry last updated: Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed