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Home > "C" Clinical Trials Conditions > Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer  Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
For Condition: ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Massachusetts General Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Screening trial to determine the significance of CA 125 levels in detecting ovarian cancer in participants who have a high genetic risk of developing ovarian cancer.
Details: OBJECTIVES: - Determine the feasibility of prospective ovarian cancer screening studies within the Cancer Genetics Network and other NCI ovarian programs for participants who are at high genetic risk for developing ovarian cancer. - Identify the logistical issues of screening these participants and their solutions within this framework. - Establish normal ranges and distributions of CA 125 values over time within and between high-risk participants, with subclassification by pre- or post-menopausal status, estrogen-replacement therapy usage, and prior prophylactic oophorectomy. - Estimate the specificity and positive predictive value of the "risk of ovarian cancer algorithm" (ROCA) suitable for designing a definitive trial of screening for ovarian cancer in high-risk participants. - Establish a longitudinal serum and plasma biorepository for retrospective evaluation of other promising biomarkers with special relevance to inherited ovarian and breast cancer risk. OUTLINE: This is a multicenter study. Participants with 1 or 2 ovaries are assigned to group A, whereas participants with prior prophylactic bilateral oophorectomy are assigned to group B. At baseline, participants in both groups undergo BRCAPRO evaluation. Participants in both groups complete a questionnaire requesting demographic information and a brief personal and family health history at baseline and a questionnaire requesting hospitalization or cancer diagnosis information at 30 months. Participants in both groups also complete health status questionnaires once every 3 months for 1-3 years. Participants undergo blood draws for measurement of CA 125 levels once every 3 months for 1-3 years. For each CA 125 measurement, the risk of ovarian cancer algorithm (ROCA) is calculated. Group A (1 or 2 ovaries at baseline): - Participants are assigned to 1 of 2 subgroups based on ROCA. - Subgroup A1: Participants with normal-risk for ovarian cancer (ROCA less than 1%) continue CA 125 screening as above. - Subgroup A2: Participants with intermediate-risk for ovarian cancer (ROCA more than 1% but less than 10%) or elevated-risk for ovarian cancer (ROCA more than 10%) undergo transvaginal sonography (TVS). Participants with elevated-risk undergo an additional blood draw for a confirmatory CA 125 level prior to TVS. Participants with normal TVS continue CA 125 screening as above. Participants with abnormal TVS are referred to a gynecologic oncologist who decides whether standard clinical intervention for potential ovarian cancer is needed. Participants who are not referred for standard clinical intervention continue CA 125 screening as above. Participants who are referred for standard clinical intervention, have at least 1 ovary remaining, and are found to have no malignancy continue CA 125 screening as above. Participants who are referred for standard clinical intervention, are found to have no malignancy, and then undergo prophylactic bilateral oophorectomy proceed to CA 125 screening as in group B below. Participants who are referred for standard clinical intervention and are found to have malignancy are taken off study. Group B (no ovaries at baseline): - Participants are assigned to 1 of 2 subgroups based on ROCA. - Subgroup B1: Participants with normal-risk for ovarian cancer (ROCA less than 5%) continue CA 125 screening as above. - Subgroup B2: Participants with elevated-risk for ovarian cancer (ROCA more than 5%) undergo an additional blood draw for a confirmatory CA 125 level and are then referred to a gynecologic oncologist who decides whether standard clinical intervention for potential ovarian cancer is needed. Participants who are not referred for standard clinical intervention continue CA 125 screening as above. Participants who are referred for standard clinical intervention and are not found to have malignancy continue CA 125 screening as above. Participants who are referred for standard clinical intervention and are found to have malignancy are taken off study. Patients are followed for clinical diagnosis for 1 additional year. PROJECTED ACCRUAL: Approximately 2,430 participants will be accrued for this study within 12 months.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 30 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Participant meet the criteria for one of the following conditions: - Participant has tested positive for BRCA1 or BRCA2 mutation or has a first- or second-degree relative with a BRCA1 or BRCA2 mutation - At least 2 ovarian or breast cancers (including ductal carcinoma in situ) have occurred among the participant and her first- and second-degree relatives within the same lineage - Condition may be satisfied by multiple primary cancers in the same person - Where breast cancer is required to meet this criterion, at least 1 breast cancer patient must have been pre-menopausal (age 50 and under at diagnosis if age at menopause unknown) - Participant is of Ashkenazi Jewish ethnicity and either has had breast cancer or has 1 first-degree or 2 second-degree relatives with breast cancer (including ductal carcinoma in situ) or ovarian cancer - Where breast cancer is required to meet this criterion, at least 1 breast cancer patient must have been pre-menopausal (age 50 and under at diagnosis if age at menopause unknown) - Probability of carrying a BRCA1 or BRCA2 mutation exceeds 20% as calculated by BRCAPRO, given family pedigree of breast cancer (including ductal carcinoma in situ) and ovarian cancer - Participant must have no prior or concurrent ovarian cancer (including low malignant potential (LMP) cancers) or primary papillary serous carcinoma of the peritoneum - Participant must not be negative for the same BRCA1 or BRCA2 mutation for which a first- or second-degree relative has tested positive - Participants who test negative for BRCA1 or BRCA2 mutation are still eligible if the pedigree or BRCAPRO criteria are satisfied, including Ashkenazi women who test negative for the three founder mutations - Documentation of family history is by participant's self-report - In relatives, ovarian cancer is defined as invasive ovarian epithelial cancers, fallopian tube cancers, or primary papillary serous carcinoma of the peritoneum - Germ cell or granulosa tumors or LMP ovarian cancers do not qualify - First- and second-degree relatives include half siblings of the participant or her first-degree relative PATIENT CHARACTERISTICS: Age: - 30 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - No hemophilia or other bleeding disorders - No serious anemia Hepatic: - Not specified Renal: - Not specified Pulmonary: - No emphysema Other: - Not pregnant - Fertile patients must use effective contraception - No psychiatric, psychological, or other conditions that would preclude informed consent - No concurrent untreated malignancy except nonmelanoma skin cancer - No medical conditions that would preclude blood draws during study - No chronic infectious disease PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 months since prior adjuvant anticancer chemotherapy Endocrine therapy: - Prior or concurrent adjuvant hormonal therapies (e.g., tamoxifen, leuprolide, or goserelin) allowed - Concurrent hormonal therapies (e.g., tamoxifen) for prevention allowed Radiotherapy: - At least 3 months since prior adjuvant anticancer radiotherapy Surgery: - At least 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy) - Prior prophylactic oophorectomy allowed Other: - At least 5 years since prior non-hormonal treatment for metastatic malignancy - No concurrent participation in other ovarian cancer early detection trials
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenSkates, Study Chair, Massachusetts General Hospital
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9125
United States
Recruiting Annette Patterson 214-648-4051
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Rana Habbal 949-824-3561
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Theresa Mickiewicz 303-724-0589
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Shelley McCormick 617-632-2164
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Judy Bacon 410-955-8964
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-4410
United States
Recruiting Beverly Powell 205-934-6309
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Lori Rippole 412-641-2501
Creighton University School of Medicine *Recruiting*
Omaha, Nebraska, 68178
United States
Recruiting Mary Benedetto 402-280-3189
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Carol Cherry 215-728-3672
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Pati Berger 515-241-8704
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Sabrina Parker 404-778-5702
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Marcia Gaul 206-215-6044
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Amanda Tweed 215-349-5679
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Kelly Mieszkalski 919-681-4556
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Paula Goldman 202-687-9490
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3264
United States
Recruiting Flo Tobar 210-562-1587
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Lakisha Lovings 713-798-1987
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Erin Morton 801-585-5004
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Maria Jung 713-745-3897
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Kelly Mieszkalski 919-681-4556
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Mary Rubins 415-353-7222
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Kathryn Post 617-726-0606
Additional Information:
Study ID Numbers: CDR0000069397; MGH-000084
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039559
Other Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
2. Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
3. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
4. Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
5. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Related Studies:
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Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
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