RecruitingNot ApplicableNCT06464107

Endometrial Cell Collection With the PadKit

Endometrial Cancer Cell Collection With the Preprogen PadKit™

Sponsor

Hackensack Meridian Health

Enrollment

80 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Neoplasms

Summary

All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium. After the kit is returned to the Preprogen laboratory, a brief survey will be completed. Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasia/malignant cells in blinded samples provided to the laboratory for analysis.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive device called the PadKit to collect cells from the lining of the uterus. Researchers want to see if it can effectively detect abnormal or cancerous cells before surgery. **You may be eligible if...** - You are a woman coming in for gynecologic surgery and have never had a hysterectomy - Either: you have been diagnosed with atypical uterine cell growth or endometrial cancer (Cohort 1), OR you are having a hysterectomy for a non-cancerous reason (Cohort 2) **You may NOT be eligible if...** - You are unable to give informed consent - You have previously had a partial hysterectomy (subtotal or supracervical) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPadKit™ from Preprogen

The interlabial pad is classified as a Class 1 device by the FDA and the device is exempt from requiring a 510(k) approval. The interlabial pad is worn for 4-6 consecutive hours and collects cells shed from the cervix and uterine cavity. The pad is then removed and placed in the smaller, inner tube that contains the transport solution. After replacing the lid securely, it is then carefully placed back inside the larger outer tube with the outer lid secured and returned to the original box. The entire box is placed in the polybag and mailed back to the lab for analysis.