Brief Title
Assessment of Screening Modalities for Gynecologic Cancers
Official Title
Assessment of Screening Modalities for Gynecologic Cancers
Brief Summary
Background:
- Endometrial and ovarian cancers are, respectively, the fourth and eighth most common
cancers among women in the United States. Although some routine Pap tests may detect the
presence of cancer cells, there are no convincing early detection approaches for either
cancer. Better methods of detection are needed.
- Two possible methods for cancer detection involve samples taken with a tampon or a
special kind of brush, called a Tao brush. Researchers would like to know more about how
well these methods work.
Objectives:
- To assess the quality of DNA collected by the tampon and Tao brush sampling methods.
- To detect genetic markers in collected DNA and determine if these markers are related to
an individual s cancer status.
Eligibility:
- Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer,
who will be having surgery.
- A control group of postmenopausal women having surgery for benign gynecological
conditions will be included.
Design:
- Shortly before hysterectomy or more extensive procedures to treat either cancer or the
benign condition:
- A tampon will be inserted into the vagina to collect cell samples, and removed after 30
minutes.
- After the tampon is removed, the cervix will be swabbed with the Tao brush to collect
cell samples.
- Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and
tested by researchers.
Detailed Description
Background:
Currently, there are no convincing early detection approaches for endometrial and ovarian
cancers. Although it is well established that some endometrial and ovarian tumors shed
cytologically recognizable cells in routinely prepared Pap tests, it is clear that this
approach rarely detects occult tumors. Accordingly, efforts to develop means of collecting
biological samples that have high patient acceptability, good sensitivity for detecting early
disease, and excellent specificity are needed.
Objectives:
In this project, we want to assess the feasibility of using alternative sampling techniques
in combination with molecular assays to detect endometrial and ovarian cancers. We will
compare sampling using a Tampon and a sheathed endometrial brush, the Tao brush. We want to
assess the quality of DNA extracted from the different samplers. We will assess the
correlations between methylation of somatic DNA for a selected marker panel and cancer
status.
Eligibility:
We wish to include 117 women age 45 years and older with suspected endometrial cancer, or
ovarian cancer, and 53 age-matched (plus/minus 5 years) controls without malignancy, all of
whom are referred to surgery at the Mayo clinic.
Design:
We plan to conduct a pilot study of women with confirmed or suspected endometrial cancer, or
ovarian cancer, and women treated for benign conditions. DNA will be extracted from samples
collected using a vaginal Tampon and an endometrial brushing using an FDA approved device
(Tao brush) prior to surgery. A panel of methylation markers will be analyzed from samples
yielding sufficient DNA. The results of the methylation analysis will be compared to the
final histology for all patients in the study. We will set the detection of methylation at
one or more loci in 50% of women in each arm as a technical success.
Study Type
Observational
Primary Outcome
Endometrial Cancer, ovarian cancer
Condition
Ovarian Cancer
Study Arms / Comparison Groups
Females
Description: With endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign reasons.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
118
Start Date
April 9, 2009
Completion Date
November 16, 2020
Primary Completion Date
September 2, 2020
Eligibility Criteria
- INCLUSION CRITERIA:
- The study will enroll a total of 170 women consented for hysterectomy. One hundred and
seventeen (117) will either have 1) suspected ovarian cancer based on clinical
impression, cytologic or histologic diagnoses (effusions, Pap tests or other
biopsies), or 2) suspected endometrial cancer based on biopsy diagnoses of atypical
endometrial hyperplasia (or its equivalent endometrial intraepithelial neoplasia),
endometrial intraepithelial carcinoma (i.e. in-situ/ early serous carcinoma) or
carcinoma. Fifty-three (53) will be undergoing definitive treatment for benign
conditions (uterine fibroids, benign appearing adnexal pathology and normal CA 125,
pelvic floor dysfunction not to exceed grade 1 or 2 uterine descensus). Since the
analyzed cancers do not occur in children, they will not be included in this study.
EXCLUSION CRITERIA:
- Surgical candidates for recurrent disease
- Preoperative neoadjuvant chemotherapy or radiotherapy
- History of tubal ligation, salpingitis, or hysterectomy (ovarian cancer patients)
- Control patients who are less than 45 years of age.
- Patients receiving treatment for active endometriosis.
- Cervical stenosis recognized clinically by not accepting the Tao Brush
- Endometrial sampling within 5 days of anticipated surgery
- Prior history of endometrial ablation
- Patients with cervical cancer
Gender
Female
Ages
50 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Nicolas Wentzensen, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00879840
Organization ID
999909121
Secondary IDs
09-C-N121
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Nicolas Wentzensen, M.D., Principal Investigator, National Cancer Institute (NCI)
Verification Date
November 2020