A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
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|ClinicalTrials.gov Identifier: NCT01787656|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2013
Last Update Posted : March 7, 2018
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 well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||438 participants|
|Official Title:||A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
- Discovery of biomarkers that allow for the early detection of ovarian cancer [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787656
|United States, Alabama|
|University of South Alabama Mitchell Cancer Institute|
|Mobile, Alabama, United States, 36604|
|Principal Investigator:||Michael A Finan, PhD||University of South Alabama|