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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01787656
First Posted: February 8, 2013
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ProHealth Care, Inc
Women's Cancer Care
University of Tennessee Cancer Institute
Arizona Oncology Associates
Sarasota Memorial Hospital
Florida Hospital Cancer Institute
Crescent City Physicians, Inc.
Sanford USD Medical Center
Monongalia General Hospital
Ochsner Health System
Sacred Heart Health System
Tennessee Valley Gynecologic Oncology
Washington University School of Medicine
Augusta University
Tulane University Health Sciences Center
Cancer Center of South Florida
Mayo Clinic
Marshall University
Indiana University
University of Arizona
St. Luke's University Health Network
Mercy Medical Center
Information provided by (Responsible Party):
Lewis Pannell, University of South Alabama
  Purpose

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
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus

Resource links provided by NLM:


Further study details as provided by Lewis Pannell, University of South Alabama:

Primary Outcome Measures:
  • Discovery of biomarkers that allow for the early detection of ovarian cancer [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
De-idetified samples of gynecologic fluid, mucus, and blood

Enrollment: 438
Study Start Date: January 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with an adenxal mass or suspicion of ovarian, fallopian tube, or primary peritoneal cancer
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Sponsors and Collaborators
University of South Alabama
ProHealth Care, Inc
Women's Cancer Care
University of Tennessee Cancer Institute
Arizona Oncology Associates
Sarasota Memorial Hospital
Florida Hospital Cancer Institute
Crescent City Physicians, Inc.
Sanford USD Medical Center
Monongalia General Hospital
Ochsner Health System
Sacred Heart Health System
Tennessee Valley Gynecologic Oncology
Washington University School of Medicine
Augusta University
Tulane University Health Sciences Center
Cancer Center of South Florida
Mayo Clinic
Marshall University
Indiana University
University of Arizona
St. Luke's University Health Network
Mercy Medical Center
Investigators
Principal Investigator: Lewis Pannell, PhD University of South Alabama
  More Information

Responsible Party: Lewis Pannell, Professor of Oncologic Sciences, University of South Alabama
ClinicalTrials.gov Identifier: NCT01787656     History of Changes
Other Study ID Numbers: USA-MCI GON-1.01
First Submitted: February 6, 2013
First Posted: February 8, 2013
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders