Endometrial Cell Collection With the PadKit

Completed · Not applicable

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT06464107

Run by

Hackensack Meridian Health

People needed

80

Starts

2024-05-31

Expected to finish

2026-04-17

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.
• Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.
• Cohort 2: women with planned hysterectomy for benign clinical indications

You may not qualify if…

• Unable to provide informed consent
• Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).

Where it is running

• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Riverview Medical Center — Red Bank, New Jersey, United States

Full record on ClinicalTrials.gov

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