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

September 15, 2020 updated by: University of South Alabama

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

438

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama Mitchell Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with an adenxal mass or suspicion of ovarian, fallopian tube, or primary peritoneal cancer

Description

Inclusion Criteria:

  1. Must be fully consented to the collection of the samples in writing (completed consent forms).
  2. Age Criteria: Women age 50 and older who are post menopausal (defined as 12 months past last menstrual period).
  3. Must have: Diagnosis of an adnexal mass or a suspicion of ovarian cancer, or a suspected fallopian tube or primary peritoneal cancer.
  4. Must have a uterus and cervix.
  5. Surgery for the adnexal mass must be anticipated. (Only patients with an adnexal mass requiring surgery will be eligible).

Exclusion Criteria:

  1. Any subject who has a condition that would increase the risk associated with the standard sampling procedures (Such as a pap smear, or cotton swab in vagina)
  2. Prior hysterectomy.
  3. Absence of adnexal mass.
  4. Primary diagnosis of a cancer other than ovarian, primary peritoneal or fallopian tube.
  5. Patients with grossly visible cervical cancer.
  6. Previous/recent treatment for any invasive gynecologic cancer.
  7. Recent chemotherapy within the prior 2 years. (recent neoadjuvant chemotherapy for ovarian cancer would exclude the patient from participation).
  8. Cervical conization within the prior 6 months.
  9. History of Radiation therapy to the pelvis, vagina or cervix.
  10. Obvious advanced stage cancer (Stage III or IV) on presentation, if known prior to specimen collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Discovery of biomarkers that allow for the early detection of ovarian cancer
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (ESTIMATE)

February 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

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.

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