Endometrial Cell Collection With the PadKit

Hackensack Meridian Health

Status: Enrolling

Conditions: Neoplasms

Treatments: Device: PadKit™ from Preprogen

Study type: Interventional

Funder types: Other

Identifiers

NCT06464107

Pro2023-0428

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy

Experimental group

Description:

Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy

Treatment:

Device: PadKit™ from Preprogen

Benign clinical indications

Experimental group

Description:

Women with planned hysterectomy for benign clinical indications

Treatment:

Device: PadKit™ from Preprogen