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PadKit for Endometrial Cancer

N/A
Recruiting
Led By Mark G Borowsky, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Unable to provide informed consent
Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the same day and after wearing the pad for 4-6 hours
Awards & highlights

Summary

This trial involves providing patients with a special pad to wear for 4-6 hours to collect cells shed by the endometrium. Once the kit is returned, a survey will be completed. The

Who is the study for?
This trial is for individuals who may have tumors affecting the lining of their uterus. Participants will use a special pad, called PadKit™ from Preprogen, to collect cells from the endometrium by wearing it for a few hours.
What is being tested?
The study is testing if the PadKit™ can effectively gather enough endometrial cells to tell apart normal cell growth from abnormal growths or cancerous cells when analyzed in a lab.
What are the potential side effects?
Since this trial involves non-invasive cell collection with a pad, there are minimal expected side effects. However, some discomfort or inconvenience while wearing the kit may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman seeing a specialist for surgery and have not had my uterus removed.
Select...
I have a biopsy showing atypical hyperplasia or endometrial cancer.
Select...
I am a woman scheduled for a hysterectomy for non-cancer reasons.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand or sign the consent form.
Select...
I have had surgery on my uterus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the same day and after wearing the pad for 4-6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the same day and after wearing the pad for 4-6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Association of the presence/absence of cells and morphology
Observation of the presence of endometrial cells captured by the pad.
Secondary study objectives
Patient preferences - Comfort
Patient preferences - Simplicity of using the pad

Trial Design

2Treatment groups
Experimental Treatment
Group I: Biopsy proven hyperplasia/endometrial cancer with planned hysterectomyExperimental Treatment1 Intervention
Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
Group II: Benign clinical indicationsExperimental Treatment1 Intervention
Women with planned hysterectomy for benign clinical indications

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
134 Previous Clinical Trials
29,843 Total Patients Enrolled
PreprogenUNKNOWN
Mark G Borowsky, MDPrincipal InvestigatorHackensack Meridian Health
~53 spots leftby May 2026
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