A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus

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 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.

Conditions

• Ovarian Cancer

Sponsors & Collaborators

• ProHealth Care, Inc

  collaborator OTHER

• Women's Cancer Care

  collaborator UNKNOWN

• University of Tennessee Cancer Institute

  collaborator OTHER

• Arizona Oncology Associates

  collaborator NETWORK

• Sarasota Memorial Hospital

  collaborator OTHER

• Florida Hospital Cancer Institute

  collaborator UNKNOWN

• Crescent City Physicians, Inc.

  collaborator OTHER

• Sanford USD Medical Center

  collaborator UNKNOWN

• Monongalia General Hospital

  collaborator UNKNOWN

• Ochsner Health System

  collaborator OTHER

• Sacred Heart Health System

  collaborator OTHER

• Tennessee Valley Gynecologic Oncology

  collaborator UNKNOWN

• Washington University School of Medicine

  collaborator OTHER

• Augusta University

  collaborator OTHER

• Tulane University Health Sciences Center

  collaborator OTHER

• Cancer Center of South Florida

  collaborator UNKNOWN

• Mayo Clinic

  collaborator OTHER

• Marshall University

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• St. Luke's Hospital and Health Network, Pennsylvania

  collaborator OTHER

• Mercy Medical Center

  collaborator OTHER

• University of South Alabama

  lead OTHER

Principal Investigators

• Michael A Finan, PhD · University of South Alabama

Eligibility

Min Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• United States

Study Locations