- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001938
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 Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Biomarker analysis
Time Frame: At 1 mo; every 3 mos; at progression or 24 mos of complete clinical remission; every 6 mos after 3 yrs on study; and annually after 5 yrs on study
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creation of protein profiles of epithelial ovarian cancer
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At 1 mo; every 3 mos; at progression or 24 mos of complete clinical remission; every 6 mos after 3 yrs on study; and annually after 5 yrs on study
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Patsner B, Orr JW Jr, Mann WJ Jr, Taylor PT, Partridge E, Allmen T. Does serum CA-125 level prior to second-look laparotomy for invasive ovarian adenocarcinoma predict size of residual disease? Gynecol Oncol. 1990 Sep;38(3):373-6. doi: 10.1016/0090-8258(90)90076-w.
- Woolas RP, Xu FJ, Jacobs IJ, Yu YH, Daly L, Berchuck A, Soper JT, Clarke-Pearson DL, Oram DH, Bast RC Jr. Elevation of multiple serum markers in patients with stage I ovarian cancer. J Natl Cancer Inst. 1993 Nov 3;85(21):1748-51. doi: 10.1093/jnci/85.21.1748.
- Rosenthal A, Jacobs I. Ovarian cancer screening. Semin Oncol. 1998 Jun;25(3):315-25. Erratum In: Semin Oncol 1998 Dec;25(6):707.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 000018
- 00-C-0018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Neoplasm
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Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedOvarian Carcinoma | Malignant Uterine Neoplasm | Malignant Female Reproductive System Neoplasm | Ovarian Neoplasm | Uterine Neoplasm | Female Reproductive System Neoplasm | Suspicious for MalignancyUnited States
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Case Comprehensive Cancer CenterCompletedMalignant Neoplasm of Ovary | Malignant Neoplasm of Fallopian Tube | Malignant Neoplasm of PeritoneumUnited States
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedSupportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological SurgeryOvarian Neoplasm | Uterine NeoplasmUnited States
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Royal Surrey County Hospital NHS Foundation TrustUnknownOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cancer | Ovarian Neoplasm | Ovarian Neoplasm EpithelialUnited Kingdom
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Azaya Therapeutics, Inc.UnknownCancer | Ovarian Cancer | Ovarian Epithelial Cancer Recurrent | Malignant Female Reproductive System Neoplasm | Ovarian TumorCanada, United States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Ovarian Carcinoma | Refractory Ovarian CarcinomaUnited States
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Catalysis SLCompletedUrogenital Neoplasms | Carcinoma | Neoplasms, Glandular and Epithelial | Endocrine System Diseases | Ovarian Diseases | Adnexal Diseases | Gonadal Disorders | Genital Diseases, Female | Ovarian Neoplasm | Female Urogenital Diseases | Endocrine Gland Neoplasm | Female Urogenital Diseases and Pregnancy Complications and other conditionsCuba
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iOMEDICO AGRecruitingCarcinoma | Ovarian Cancer | Endometrial Neoplasms | Endometrial Cancer | Ovary Neoplasm | Neoplasm, Ovarian | Carcinoma, OvarianGermany
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Karolinska InstitutetKarolinska University Hospital; Umeå University; Leiden University; Dalarna University and other collaboratorsRecruitingNeoplasm, Breast | Neoplasm, Colorectal | Neoplasm, OvarianSweden