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A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) Clinical research trials and A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse). A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse) condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)  A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)
A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)
For Condition: Ovarian Neoplasm
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Every cell in the human body contains hundreds of thousands of genes and the proteins made by the genes. Sometimes changes take place in the genes or proteins that may make the cells more likely to develop into cancer. An experimental protein profile test that finds these changes may be able to provide information about whose cancer will stay in remission and whose will return. Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this study. Specimens will be collected from blood, saliva, and urine for the first protein profile test. Sample sets for more protein profile tests will be collected at follow-up visits 1 month and 3 months later and every 3 months afterward. If and when the cancer returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be taken both for a protein profile test and for review of the function and structure of the disease (pathology review). The protein profiles from these samples will be compared to those samples already collected to detect protein pattern changes. The amount of lysophosphatidic acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is useful in detecting the return of ovarian cancer. If patients get fluid in the stomach or chest, it will be tested for cancer cells and proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the cancer, a biopsy will be performed and a sample saved for a protein profile.
Details: Over 80% of advanced stage epithelial cancer patients relapse after attaining first clinical remission with standard platinum/paclitaxel-based chemotherapy. Surrogate biomarkers are needed for the evaluation of efficacy of treatment and for use as predictors of disease in screening and for relapse diagnosis. CA-125, the existing ovarian cancer marker, will become elevated with relapse in some but not all of the approximately 80% of patients for whom it was increased at initial diagnosis. Elevation in CA-125 may precede clinical evidence of relapse by as much as 6-10 months or lag behind clinical relapse by the same time intervals, making it a less than satisfactory clinical tool. Emerging proteomic technologies allow for scanning of cellular proteins in a simple, short, reproducible, and quantitative chemical assay. We hypothesize that changes in a patient's protein pattern will be detectable and will be reliably associated with relapse. This protocol is a pilot study for our ability to ascertain and evaluate samples from ovarian cancer patients followed in first clinical remission, and investigate whether analysis of sequential protein fingerprints will yield a reproducible pattern of change that may be associated with relapse.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA All patients in first clinical remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma or stage IIC clear cell histology epithelial ovarian cancer as defined by: normal CA-125, normal physical exam, normal post hysterectomy pelvic examination, no evidence of disease on CT scan or other noninvasive reassessment. Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy). S/P completion of primary therapy with standard platinum/paclitaxel or carboplatin/paclitaxel-containing chemotherapy and in confirmed clinical complete response. At least one block from the primary tumor must be received. (If available, a sample of frozen primary tumor should also be forwarded). ECOG performance status of 0, 1, or 2. EXCLUSION CRITERIA Patients with nonepithelial ovarian cancer, or mixed epithelial/nonepithelial ovarian cancer. Patients may not be receiving chemotherapy, hormonal therapy, alternative therapy, or radiation therapy. No therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is not allowed.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Mary Lewis 3014355612
Additional Information:
Study ID Numbers: 000018; 00-C-0018
Study Start Date: November 16, 1999
Record last reviewed: November 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001938
Other Ovarian Neoplasm Studies:
1. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
2. Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
3. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
4. Phase II CT-2103/Carboplatin in Ovarian Cancer
5. Experimental Drug SS1(dsFv)-PE38 to Treat Cancer
Related Studies:
Other Ovarian Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)
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