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CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women Clinical research trials and CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women. CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women clinical trial. Test subjects oftentimes recieve the best healthcare possible for their CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women  CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
For Condition: ovarian epithelial cancer
Status: Not yet recruiting
Sponsor(s): St. Bartholomew's Hospital ,
Synopsis: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known if ultrasound is more effective with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women. PURPOSE: Randomized clinical trial to study the effectiveness of ultrasound with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.
Details: OBJECTIVES: - Determine the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality in postmenopausal women. - Determine the physical morbidity of ovarian cancer screening in this population. - Determine the psychological consequences of screening results (true negative, true positive, false negative, and false positive) in this population. - Compare the interventions that result from screening for ovarian cancer using CA 125 monitoring and ultrasound in this population. - Compare the feasibility of population screening, in terms of compliance rates with annual screening for ovarian cancer with these strategies. - Compare the performance of these screening strategies in this population. OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3 screening arms. - Arm I: Participants do not undergo screening. - Arm II: Participants undergo screening with an annual CA 125 level. Depending on the results of the test, some patients may undergo additional screening. - Arm III: Participants undergo screening with an annual transvaginal or transabdominal ultrasound. Depending on the results of the test, some patients may undergo additional screening. Participants in all arms complete a health questionnaire at 3.5 and 7 years after study entry. PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for arms II and III) will be accrued for this study within 3 years.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 50 Years/74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Postmenopausal, as defined by meeting 1 of the following criteria: - More than 12 months of amenorrhea after natural menopause or hysterectomy - Received more than 12 months of hormone replacement therapy for menopausal symptoms - No prior ovarian malignancy - No prior bilateral oophorectomy - Not at high risk for ovarian cancer due to familial predisposition as defined by the UKCCCR Familial Ovarian Cancer Screening Study PATIENT CHARACTERISTICS: Age - 50 to 74 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No active non-ovarian malignancy - Prior malignancy allowed provided there is no documented persistent or recurrent disease and patient has not received treatment for more than 1 year PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No concurrent participation in any other ovarian cancer screening study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
UshaMenon, Study Chair, St. Bartholomew's Hospital
Additional Information:
Study ID Numbers: CDR0000285690; UKCTOCS,EU-20249
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058032
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. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
3. Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
4. Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
5. Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
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CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
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