Clinical trial NCT01787656: A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
Official title: A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: University of South Alabama
Sponsor class: OTHER
Collaborators: name: ProHealth Care, Inc
name: Women's Cancer Care
name: University of Tennessee Cancer Institute
name: Arizona Oncology Associates
name: Sarasota Memorial Hospital
name: Florida Hospital Cancer Institute
name: Crescent City Physicians, Inc.
name: Sanford USD Medical Center
name: Monongalia General Hospital
name: Ochsner Health System
name: Sacred Heart Health System
name: Tennessee Valley Gynecologic Oncology
name: Washington University School of Medicine
name: Augusta University
name: Tulane University Health Sciences Center
name: Cancer Center of South Florida
name: Mayo Clinic
name: Marshall University
name: Indiana University
name: University of Arizona
name: St. Luke's Hospital and Health Network, Pennsylvania
name: Mercy Medical Center
First posted: 2013-02-08
Enrollment: 438
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women with an adenxal mass or suspicion of ovarian, fallopian tube, or primary peritoneal cancer

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Discovery of biomarkers that allow for the early detection of ovarian cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
Study officials:
affiliation: University of South Alabama
name: Michael A Finan, PhD
role: PRINCIPAL_INVESTIGATOR
References: