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Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

NCT00005095
Conditions
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Ovarian Cancer, Sarcoma, Uterine Leiomyomata, Vaginal Cancer, Vulvar Cancer
Interventions
Ca-125, screening questionnaire administration, Surgery
Other · Procedure
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 80 Years · Female only
Enrollment
6,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2000 – 2040
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Fallopian Tube Cancer, Ovarian Sarcoma, Ovarian Stromal Cancer, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Uterine Sarcoma, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Uterine Sarcoma, Stage III Vaginal Cancer, Stage III Vulvar Cancer, Stage IV Endometrial Carcinoma, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Uterine Sarcoma, Stage IV Vulvar Cancer, Stage IVA Cervical Cancer, Stage IVA Vaginal Cancer, Stage IVB Cervical Cancer, Stage IVB Vaginal Cancer
Interventions
stereotactic radiosurgery, quality-of-life assessment
Radiation · Procedure
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Leydig Cell Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Pseudomyxoma Peritonei, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Primary Peritoneal Cavity Cancer, Recurrent Uterine Sarcoma, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer
Interventions
stereotactic body radiation therapy, carboplatin, gemcitabine hydrochloride, laboratory biomarker analysis, pharmacogenomic studies
Radiation · Drug · Other
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
19 Years and older · Female only
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Cancer
Interventions
ziv-aflibercept
Biological
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 120 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
2
States / cities
New York, New York • Nashville, Tennessee
Conditions
Cancer
Interventions
docetaxel, thalidomide
Drug
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2006
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Breast Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
BMS-247550
Drug
Lead sponsor
Albert Einstein College of Medicine
Other
Eligibility
18 Years to 120 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2004
U.S. locations
2
States / cities
New York, New York • The Bronx, New York
Conditions
Pleuropulmonary Blastoma, Cystic Nephroma, Sertoli-Leydig Cell Tumor of Ovary, Medulloepithelioma, Embryonal Rhabdomyosarcoma of Cervix, Goiter, Sarcoma, Pineoblastoma, Pituitary Tumors, Wilms Tumor
Interventions
Not listed
Lead sponsor
Ashley Hill
Other
Eligibility
1 Day to 95 Years
Enrollment
1,247 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2022
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Conditions
Ovarian Cancer
Interventions
radionuclide imaging, indium In 111 folic acid
Procedure · Radiation
Lead sponsor
Endocyte
Industry
Eligibility
18 Years to 120 Years · Female only
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2000
U.S. locations
3
States / cities
Indianapolis, Indiana • St Louis, Missouri • Houston, Texas
Conditions
Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Stromal Tumor, Nausea and Vomiting, Ovarian Cancer, Pancreatic Cancer, Peritoneal Cavity Cancer, Small Intestine Cancer
Interventions
octreotide acetate
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2002
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer, Localized Gastrointestinal Carcinoid Tumor, Localized Resectable Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Metastatic Gastrointestinal Carcinoid Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Primary Peritoneal Cavity Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Adult Soft Tissue Sarcoma, Recurrent Colon Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Small Intestine Cancer, Recurrent Uterine Sarcoma, Regional Gastrointestinal Carcinoid Tumor, Small Intestine Adenocarcinoma, Small Intestine Leiomyosarcoma, Small Intestine Lymphoma, Stage 0 Non-small Cell Lung Cancer, Stage I Adult Soft Tissue Sarcoma, Stage I Colon Cancer, Stage I Gastric Cancer, Stage I Non-small Cell Lung Cancer, Stage I Ovarian Epithelial Cancer, Stage I Ovarian Germ Cell Tumor, Stage I Pancreatic Cancer, Stage I Rectal Cancer, Stage I Uterine Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage II Colon Cancer, Stage II Gastric Cancer, Stage II Non-small Cell Lung Cancer, Stage II Ovarian Epithelial Cancer, Stage II Ovarian Germ Cell Tumor, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage II Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Uterine Sarcoma, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Adult Soft Tissue Sarcoma, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Uterine Sarcoma, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
Interventions
EF5, motexafin lutetium, pharmacological study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Interventions
imatinib mesylate
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2002
U.S. locations
2
States / cities
Bethesda, Maryland
Conditions
Bladder Cancer, Breast Cancer, Carcinoma of Unknown Primary, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Lung Cancer, Melanoma (Skin), Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Sarcoma
Interventions
filgrastim, docetaxel, gemcitabine hydrochloride
Biological · Drug
Lead sponsor
Dartmouth-Hitchcock Medical Center
Other
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2005
U.S. locations
1
States / cities
Lebanon, New Hampshire
Conditions
Cancer
Interventions
therapeutic allogeneic lymphocytes
Biological
Lead sponsor
University of Medicine and Dentistry of New Jersey
Other
Eligibility
Not listed
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2011
U.S. locations
1
States / cities
New Brunswick, New Jersey
Conditions
Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
oblimersen sodium, docetaxel
Biological · Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2002
U.S. locations
1
States / cities
New York, New York
Conditions
Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Gastrointestinal Stromal Tumor, Premenopausal
Interventions
Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Questionnaire Administration, Ultrasonography
Other · Procedure
Lead sponsor
University of Southern California
Other
Eligibility
18 Years to 45 Years · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2024
U.S. locations
1
States / cities
Los Angeles, California
Conditions
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Pain, Perioperative/Postoperative Complications, Sarcoma
Interventions
fentanyl citrate, hydromorphone hydrochloride, ropivacaine hydrochloride
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
Female only
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
1
States / cities
San Francisco, California
Conditions
Cancer
Interventions
Fentanyl sublingual spray, Placebo
Drug
Lead sponsor
INSYS Therapeutics Inc
Industry
Eligibility
18 Years and older
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Chandler, Arizona
Conditions
Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer, Endometrial Cancer
Interventions
Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min, Tinostamustine 60mg/m2 over 60min, Tinostamustine 80mg/m2 over 60min, Tinostamustine 100mg/m2 over 60min, Tinostamustine 80mg/m2 over 80min
Drug
Lead sponsor
Mundipharma Research Limited
Industry
Eligibility
18 Years and older
Enrollment
71 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
5
States / cities
Los Angeles, California • Palo Alto, California • Ann Arbor, Michigan + 2 more
Conditions
Adult Alveolar Soft Part Sarcoma, Adult Angiosarcoma, Adult Desmoplastic Small Round Cell Tumor, Adult Epithelioid Hemangioendothelioma, Adult Epithelioid Sarcoma, Adult Extraskeletal Myxoid Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Mesenchymoma, Adult Malignant Peripheral Nerve Sheath Tumor, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Adult Unclassified Pleomorphic Sarcoma, Chondrosarcoma, Clear Cell Sarcoma of the Kidney, Conjunctival Kaposi Sarcoma, Dermatofibrosarcoma Protuberans, Gastrointestinal Stromal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Osteosarcoma, Ovarian Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Adult Unclassified Pleomorphic Sarcoma of Bone, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Kaposi Sarcoma, Recurrent Osteosarcoma, Recurrent Uterine Corpus Sarcoma, Small Intestine Leiomyosarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine Sarcoma, Unclassified Pleomorphic Sarcoma of Bone
Interventions
Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Pharmacological Study, Vismodegib
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2015
U.S. locations
1
States / cities
New York, New York
Conditions
Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vaginal Cancer
Interventions
capecitabine, brachytherapy, radiation therapy
Drug · Radiation
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2005
U.S. locations
2
States / cities
Cleveland, Ohio
Conditions
Cancer
Interventions
vorinostat
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2008
U.S. locations
1
States / cities
New York, New York
Conditions
Breast Cancer, Leukemia, Lymphoma, Neuroblastoma, Ovarian Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
filgrastim, amifostine trihydrate, cyclophosphamide, melphalan, peripheral blood stem cell transplantation
Biological · Drug · Procedure
Lead sponsor
University of Kentucky
Other
Eligibility
14 Years to 70 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1997
U.S. locations
4
States / cities
Lexington, Kentucky • Baltimore, Maryland • Philadelphia, Pennsylvania + 1 more
Conditions
Malignant Ovarian Epithelial Tumor, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Refractory Fallopian Tube Carcinoma, Refractory Ovarian Carcinoma, Refractory Primary Peritoneal Carcinoma
Interventions
Akt/ERK Inhibitor ONC201, Paclitaxel, Questionnaire Administration
Drug · Other
Lead sponsor
Ira Winer
Other
Eligibility
18 Years and older · Female only
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
2
States / cities
Detroit, Michigan • Flint, Michigan
Conditions
Cancer
Interventions
ziv-aflibercept
Biological
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 120 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
1
States / cities
New York, New York