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NCT01787656 · ClinicalTrials.gov registry record
A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
A clinical trial, sponsored by University of South Alabama.
- Completed
- Registry status
- 438
- Enrollment target
NCT01787656: Completed study, sponsored by University of South Alabama.
NCT01787656 is a clinical trial that has completed, run by University of South Alabama. The registered enrollment target is 438 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01787656 has completed, sponsored by University of South Alabama.
- COMPLETED
- Registry status
- 438 participants
- Enrollment target
Study Summary
Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system. We have examined this fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian cancer when compared against healthy controls. These markers will be initially refined using the comparison of ovarian cancer patients against those with benign adnexal masses that entered the clinic during the same time period. In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the w
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01787656
The ClinicalTrials.gov registry entry for NCT01787656 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Alabama, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01787656 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01787656 about?
NCT01787656 is a clinical study titled "A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus". Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is...
What is the current status of trial NCT01787656?
This trial is currently completed. The enrollment target is 438 participants. The study started on 2013-01. Estimated completion is 2018-08.
Who is sponsoring clinical trial NCT01787656?
This trial is sponsored by University of South Alabama, which has 17 total clinical trials registered on ClinicalTrials.gov.
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