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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787656
• Other study ID #: USA-MCI GON-1.01
• Status: Completed
• Start date: January 2013
• Est. completion date: August 2018

Study information

• Verified date: September 2020
• Source: University of South Alabama
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama

Sponsors (23)

Lead Sponsor

Collaborator

University of South Alabama

Arizona Oncology Associates, Augusta University, Cancer Center of South Florida, Crescent City Physicians, Inc., Florida Hospital Cancer Institute, Indiana University, Marshall University, Mayo Clinic, Mercy Medical Center, Monongalia General Hospital, Ochsner Health System, ProHealth Care, Inc, Sacred Heart Health System, Sanford USD Medical Center, Sarasota Memorial Hospital, St. Luke's Hospital and Health Network, Pennsylvania, Tennessee Valley Gynecologic Oncology, Tulane University Health Sciences Center, University of Arizona, University of Tennessee Cancer Institute, Washington University School of Medicine, Women's Cancer Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discovery of biomarkers that allow for the early detection of ovarian cancer		3 years