A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-002226
NCT ID: NCT01787656
Sponsor Protocol Number: USA_MCI GON-1.04
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Must be fully consented to the collection of the samples in writing (completed consent forms)
- Women age 50 and older who are post menopausal (defined as 12 months past last menstrual period)
- Must have a diagnosis of an adnexal mass or a suspicion of ovarian cancer, or a suspected fallopian tube or primary peritoneal cancer
- Must have a uterus and cervix
- Surgery for the adnexal mass must be anticipated. (Only patients with an adnexal mass requiring surgery will be eligible)
Exclusion Criteria
- Any subject who has a condition that would increase the risk associated with the standard sampling procedures (such as the pap smear or using a cotton swab in the vagina)
- Prior hysterectomy
- Absence of adnexal mass
- Primary diagnosis of a cancer other than ovarian, primary peritoneal or fallopian tube
- Patients with grossly visible cervical cancer
- Previous/recent treatment for any invasive gynecologic cancer
- Recent chemotherapy within the prior 2 years. (recent neoadjuvant chemotherapy for ovarian cancer would exclude the patient from participation)
- Cervical conization within the prior 6 months
- History of Radiation therapy to the pelvis, vagina or cervix
- Obvious advanced stage cancer (Stage III or IV) on presentation, if known prior to specimen collection.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jamie Bakkum-Gamez, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available