Collecting endometrial cells using the PadKit
Endometrial Cancer Cell Collection With the Preprogen PadKit™
This study is testing if a special pad can help women collect endometrial cells to see if they have normal or abnormal cells during gynecologic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 2 sites (Neptune, New Jersey and 1 other locations) |
| Trial ID | NCT06464107 on ClinicalTrials.gov |
What this trial studies
This study involves women who are undergoing surgical intervention for gynecologic conditions. Participants will wear a Preprogen Pad for 4-6 hours to collect cells shed from the endometrium. The collected samples will be sent to a laboratory for analysis to determine if the PadKit can effectively differentiate between normal and atypical hyperplasia or malignant cells. A brief survey will also be completed by participants after returning the kit.
Who should consider this trial
Good fit: Ideal candidates are women presenting for surgical intervention in gynecologic oncology, specifically those with biopsy-proven atypical hyperplasia or endometrial cancer, as well as those with planned hysterectomy for benign reasons.
Not a fit: Patients who have previously undergone uterine surgery or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method for early detection of endometrial cancer and related conditions.
How similar studies have performed: While similar approaches have been explored, this specific method using the PadKit for endometrial cell collection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy. 1. Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer. 2. Cohort 2: women with planned hysterectomy for benign clinical indications Exclusion criteria 1. Unable to provide informed consent 2. Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).
Where this trial is running
Neptune, New Jersey and 1 other locations
- Jersey Shore University Medical Center — Neptune, New Jersey, United States (Recruiting)
- Riverview Medical Center — Red Bank, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Mark G Borowsky, MD — Hackensack Meridian Health
- Study coordinator: Danielle Kwiatkowski
- Email: danielle.kwiatkowski@hmhn.org
- Phone: 732-897-3923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.