A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2013 |
| End Date: | August 2018 |
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.
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.
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.
We found this trial at
1
site
1660 Springhill Avenue
Mobile, Alabama 36604
Mobile, Alabama 36604
(251) 665-8000
Phone: 251-665-8000
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
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