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Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer Clinical research trials and Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer. Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer  Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer
Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer
For Condition: ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Surgery to remove the fallopian tubes and ovaries may decrease the risk of ovarian cancer and may improve quality of life in women who are at increased genetic risk. Monitoring CA 125 levels may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Screeningtrial to study the effectiveness of surgery to remove the fallopian tubes and ovaries combined with monitoring of CA 125 levels in participants who are at increased genetic risk for ovarian cancer.
Details: OBJECTIVES: - Compare the prospective incidence of ovarian cancer, breast cancer, fallopian tube cancer, primary peritoneal cancer, and all cancer in participants at increased genetic risk of ovarian cancer who undergo risk-reducing salpingo-oophorectomy (RRSO) or CA 125 screening. - Determine the prevalence of clinically occult ovarian cancer and fallopian tube cancer and precursor lesions in participants who undergo RRSO. - Determine the positive predictive value and specificity of the Risk of Ovarian Cancer Algorithm (ROCA) based on serial CA 125 measurements for ovarian cancer in participants who do not undergo RRSO. - Compare quality of life, sexual functioning, frequency of menopausal symptoms, depression, anxiety, cancer worry, and concerns associated with familial risk of ovarian cancer in participants who undergo RRSO vs screening. - Compare changes in these quality of life parameters over time in these participants. - Determine patterns of use of medications (e.g., tamoxifen, raloxifene, estrogen or hormonal replacement therapy (HRT), alendronate, or vaginal estrogens) that may alter the risk of important medical outcomes (e.g., cancer endpoints or estrogen deficiency disorders) in these participants. - Monitor overall mortality and the incidence of various disease states that complicate long-term estrogen deficiency (e.g., osteoporosis, skeletal fractures, coronary artery disease, or myocardial infarction) in these participants. - Monitor these participants' and their health care providers' adherence to recommendations regarding the management of non-oncologic morbidity related to premature menopause. - Analyze the factors (regarding cancer risk reduction and screening activities) that influence a woman's choice between RRSO vs screening. - Establish normal ranges and distributions within and between high-risk participants for CA 125 values over time, with sub-classification by pre/postmenopausal status, HRT usage, RRSO status, and other risk factors. OUTLINE: This is a multicenter study. Participants choose 1 of 2 screening/prevention groups. - Group I (screening): Participants undergo genetic risk, medical and ovarian cancer risk factor, and quality of life (QOL) assessment; transvaginal ultrasound (TVUS); and CA 125 measurement. CA 125 is measured every 3 months and the Risk of Ovarian Cancer Algorithm (ROCA) is determined. QOL is assessed every 6 months. TVUS is repeated annually (unless ovaries have been removed) as is a mammogram. If screening tests are abnormal, TVUS may be repeated and laparotomy/laparoscopy may be performed if a malignancy is suspected or a benign finding requires surgery. - Group II (risk-reducing surgery): Participants undergo genetic risk, medical and ovarian cancer risk factor, and QOL assessment; TVUS; and CA 125 measurement. Participants then undergo risk-reducing salpingo-oophorectomy (RRSO). CA 125 is measured and ROCA calculated every 3 months. QOL is assessed every 6 months and a mammogram is performed annually. Abnormal screening results are treated as in group I. Participants in group I who decide to undergo RRSO may cross-over to group II at any time. QOL is assessed in both groups every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 1,800 participants (800 for group I and 1,000 for group II) will be accrued for this study within 2 years.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 30 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - At increased genetic risk of ovarian cancer - No prior history of ovarian cancer, including low malignant potential cancers, or primary papillary serous carcinoma of the peritoneum - Must have one of the following as ovary status: - At least 1 intact ovary (for risk-reducing salpingo-oophorectomy group or screening group with primary ovarian cancer as endpoint) - Both ovaries and fallopian tubes removed while participating in GOG-0199 (for screening group with primary peritoneal cancer as endpoint) - Must meet 1 of the following criteria: - Documented deleterious BRCA1 or BRCA2 mutation in either participant or first- or second-degree relative - Family contains at least 2 ovarian and/or breast cancers among the participant or first- or second-degree relatives within the same lineage - Multiple primary cancers in same person satisfies this criterion - At least 1 breast cancer must be premenopausal (age 50 or under at diagnosis if age at menopause unknown) - Participant is of Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with breast and/or ovarian cancer - At least 1 breast cancer must be premenopausal (age 50 or under at diagnosis if age at menopause unknown) - Participant is of Ashkenazi ancestry and has had premenopausal breast cancer - Probability of carrying a BRCA1/2 mutation given the family pedigree of breast and ovarian cancer exceeds 20% as calculated by BRCAPRO - First- or second-degree relative may include half-siblings of the participant or a first-degree relative - Ovarian cancer in relatives may include any of the following: - Invasive ovarian epithelial cancer - Fallopian tube cancer - Primary papillary serous carcinoma of the peritoneum - No germ cell tumors, granulosa cell tumors, or ovarian tumors of low malignant potential in relatives - Prior history of breast cancer is allowed and may include any of the following: - Ductal carcinoma in situ - Positive regional lymph nodes (loco-regional disease) - No bilateral oophorectomy performed before study entry - Must be willing to disclose BRCA mutation status (if known) or willing to be tested for BRCA mutation (if not previously tested) PATIENT CHARACTERISTICS: Age - 30 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or planning pregnancy - No psychiatric, psychological, or other conditions that would preclude informed consent - No prior medical condition (e.g., chronic infectious disease, severe anemia, or hemophilia) that would preclude donating blood for research purposes - No prior metastatic malignant disease requiring therapy within the past 5 years - No concurrent untreated malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 1 month since prior adjuvant chemotherapy - No concurrent chemotherapy Endocrine therapy - Concurrent adjuvant hormonal therapy (e.g., tamoxifen, raloxifene, or arimidex) allowed - Concurrent hormonal therapy (e.g., tamoxifen, raloxifene, or hormone replacement therapy) for cancer prevention, management of cardiovascular or bone disorders related to estrogen deficiency, or treatment of menopausal symptoms allowed Radiotherapy - At least 1 month since prior adjuvant radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - At least 3 months since prior intraperitoneal surgery (including laparoscopy) - Prior prophylactic oophorectomy allowed provided surgery was performed on current protocol* NOTE: *For screening group with primary peritoneal cancer as endpoint Other - No concurrent participation in another ovarian cancer early detection trial
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkGreene, Study Chair, Clinical Genetics Branch
St. Francis Cancer Center *Recruiting*
Hartford, Connecticut, 06105
United States
Recruiting Elieen Pond-Levine 860-714-7701
Rocky Mountain Cancer Centers - Midtown *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Natalie Gould 303-388-4876
Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Suzanne Villarreal 901-226-1673
Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos, California, 95032
United States
Recruiting Karen Marasigan 408-866-3843
Ella Milbank Foshay Cancer Center at Jupiter Medical Center *Recruiting*
Jupiter, Florida, 33458
United States
Recruiting Marcia Cage 561-745-5768
Santa Clara Valley Medical Center *Recruiting*
San Jose, California, 95128
United States
Recruiting Ngami Tran 408-378-9173
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Chris Henson 503-494-3916
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Elsa Dedman 808-983-6090
Clinical Genetics Branch *Recruiting*
Rockville, Maryland, 20892
United States
Recruiting Jennifer Loud 301-594-7642
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Christine Smith 919-966-5996
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
Bayfront Medical Center *Recruiting*
Saint Petersburg, Florida, 33701
United States
Recruiting Tabitha Swartz 727-821-9688
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Franklin Square Hospital Center *Recruiting*
Baltimore, Maryland, 21237
United States
Recruiting Karen Oleszewski 443-777-7136
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting Gladys Pierce 402-354-5129
New Britain General Hospital *Recruiting*
New Britain, Connecticut, 06050
United States
Recruiting Maureen Bracco 860-224-5900
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Joyce Seldon 310-794-7576
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting Gayle Guenthard 310-794-9093
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Jessica Roberts 410-955-8849
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7357
United States
Recruiting Holly Smith 913-588-4709
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Elisa Eldermire 216-844-8787
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Michaelene Bianchi 412-641-6448
Union Memorial Hospital *Recruiting*
Baltimore, Maryland, 21218
United States
Recruiting Ruth Diggs 410-554-2125
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Mary Santos 646-227-2252
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0209
United States
Recruiting Lis Schafer 409-747-0250
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting Nancy Blades 806-359-4673
University of New Mexico Health Science Center *Recruiting*
Albuquerque, New Mexico, 87131-5286
United States
Recruiting Suzanne Monroy 505-272-6665
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Bobbi Cobb 614-293-3873
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Kathy Phipps 603-653-3537
Florida Gynecologic Oncology - Fort Myers *Recruiting*
Ft. Myers, Florida, 33901
United States
Recruiting June Davis 239-334-5917
Sioux Valley Hospital at University of South Dakota Medical Center *Recruiting*
Sioux Falls, South Dakota, 57117-5039
United States
Recruiting Sharon Hoon 605-357-1592
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Kim Strickland 501-269-1099
U.T. Cancer Institute at University of Tennessee Medical Center *Recruiting*
Knoxville, Tennessee, 37920-6999
United States
Recruiting Becky Libby 865-673-9250
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8028
United States
Recruiting Linda Rinky 203-795-6128
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Debra Deeken 573-882-1057
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Pat Mitchell 434-982-1659
Cancer Care Associates *Recruiting*
Tulsa, Oklahoma, 74133
United States
Recruiting Sharon Franklin 918-499-2000
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Pat Young 910-215-2200
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Alicia Daly 732-235-7457
Glendale Memorial Hospital Comprehensive Cancer Center *Recruiting*
Glendale, California, 91204
United States
Recruiting Veronica Hudson 818-905-1901
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-3236
United States
Recruiting Linda Harris 608-263-8600
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Jill Burton 507-284-8440
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Linda Henderson 847-570-1173
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Beth Bement 605-719-6075
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting Rena Mock 405-271-8777
Hartford Hospital *Recruiting*
Hartford, Connecticut, 06102-5037
United States
Recruiting Camille Servodidio 860-545-5362
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lois Winkelman 312-924-6723
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Mayo Clinic Scottsdale *Recruiting*
Scottsdale, Arizona, 85259
United States
Recruiting Lynn Boyer 480-301-4446
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Ochsner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Laurie Gwilliam 504-842-3708
Hillcrest Hospital *Recruiting*
Mayfield Heights, Ohio, 44124
United States
Recruiting Mary Smrekar 440-312-7226
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Riverside Methodist Hospital *Recruiting*
Columbus, Ohio, 43214-3998
United States
Recruiting Patti Dunn 740-549-5462
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Zenona Lesko 212-263-8737
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Molly Daniels 713-745-8902
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Maria Defrancesco 856-963-3760
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Washington Hospital Center *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Natalie Bongiorno 202-877-8517
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting Aimee Minton 631-444-2858
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Carol Brudenell 954-267-7704
Additional Information:
Study ID Numbers: CDR0000257695; GOG-0199,NCI-02-C-0268
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049049
Other Ovarian Epithelial Cancer Studies:
1. Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
2. Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
3. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
4. Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
5. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
Related Studies:
Other ovarian epithelial cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer
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