Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001938
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2000-01-18
Brief Title:
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
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission Development of a Protein Fingerprint Profile Associated With Relapse
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Over 80 percent of advanced stage epithelial cancer patients relapse after attaining first clinical remission with standard platinumpaclitaxel-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 80 percent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0018 | None | None | None |