Endometrial Cell Collection With the PadKit

Last updated: April 18, 2025
Sponsor: Hackensack Meridian Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

PadKit™ from Preprogen

Clinical Study ID

NCT06464107
Pro2023-0428
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion criteria

  1. Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.

  2. Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.

  3. 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).

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: PadKit™ from Preprogen
Phase:
Study Start date:
May 31, 2024
Estimated Completion Date:
May 30, 2026

Connect with a study center

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Active - Recruiting

  • Riverview Medical Center

    Red Bank, New Jersey 07701
    United States

    Active - Recruiting

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