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Endometrial Cell Collection With the PadKit

RECRUITINGN/ASponsored by Hackensack Meridian Health
Actively Recruiting
PhaseN/A
SponsorHackensack Meridian Health
Started2024-05-31
Est. completion2026-05-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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).

Conditions2

CancerNeoplasms

Locations2 sites

Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Danielle DeBouter732-897-2066danielle.debouter@hmhn.org
Riverview Medical Center
Red Bank, New Jersey, 07701
Danielle DeBouter732-897-2066danielle.debouter@hmhn.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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