Endometrial Cell Collection With the PadKit

Last updated: May 12, 2026
Sponsor: Hackensack Meridian Health
Overall Status: Completed

Phase

N/A

Condition

Endometriosis

Endometrial Cancer

Dysfunctional Uterine Bleeding

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:
April 17, 2026

Connect with a study center

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Riverview Medical Center

    Red Bank, New Jersey 07701
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • Riverview Medical Center

    Red Bank 5103159, New Jersey 5101760 07701
    United States

    Site Not Available

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