Endometrial Cell Collection With the PadKit
NCT06464107
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
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
Locations2 sites
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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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NCT06464107