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Endometrial Cell Collection With the PadKit

NCT06464107RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Hackensack Meridian Health

Enrollment

Start Date

2024-05-31

Completion Date

2026-05-30

Study Type

INTERVENTIONAL

Official Title

Endometrial Cancer Cell Collection With the Preprogen PadKit™

Interventions

PadKit™ from Preprogen

Conditions

Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

Observation of the presence of endometrial cells captured by the pad.

Direct observation of the absence or presence of endometrial cells on the pad by the pathologist

Time frame: Within 7 days after receipt of the pad from patients

Association of the presence/absence of cells and morphology

Analysis for the presence of abnormal histology and morphological classification as normal, hyperplastic, or malignant.

Time frame: Within 7 days after receipt of the pad from patients

Secondary Outcomes

Patient preferences - Comfort

To determine patient preferences for using the interlabial PadKit™ vs current standard of care diagnostic tools including transvaginal ultrasound, endometrial biopsy, CT scan, and/or Dilation \& Curettage (D\&C). Patient preferences regarding comfort of wearing the pad are captured using a 1-3 Likert scale with 1 being not comfortable and 3 being comfortable.

Time frame: Within the same day and after wearing the pad for 4-6 hours

Patient preferences - Simplicity of using the pad

To determine patient preferences for using the interlabial PadKit™ vs current standard of care diagnostic tools including transvaginal ultrasound, endometrial biopsy, CT scan, and/or Dilation \& Curettage (D\&C). Patient preferences regarding simplicity of using the pad are captured using a 4 Likert scale with 1 being not easy and 4 being very easy.

Time frame: Within the same day and after wearing the pad for 4-6 hours

Locations

Jersey Shore University Medical Center, Neptune City, United States

Riverview Medical Center, Red Bank, United States

Linked Papers

2019-11-28

Combining copy number, methylation markers, and mutations as a panel for endometrial cancer detection via intravaginal tampon collection

We aimed to assess whether endometrial cancer (EC) can be detected in shed DNA collected with vaginal tampon by analyzing copy number, methylation markers, and mutations. Tampons were collected prior to hysterectomy from 38 EC patients and 28 women with benign indications. Extracted tampon DNA underwent the following: 1) low-coverage whole genome sequencing (LC-WGS) to assess copy number, 2) pyrosequencing to measure percent promotor methylation of HOXA9, RASSF1, and CDH13 and 3) next generation sequencing (NGS) to identify mutations in 19 genes associated with EC identified through The Cancer Genome Atlas. Sensitivity and specificity for each test and test combinations were calculated. Methylation analysis yielded the highest specificities but lowest sensitivities (37-40% sensitivity; 100% specificity for HOXA9, RASSF1 and HTR1B) while mutation analysis had improved sensitivity (50% sensitivity; 83% specificity). Only one "false positive" result for copy number variants was identified among women with benign surgical indications, which was based on detection of copy number changes, and associated with a leiomyosarcoma that was only recognized at hysterectomy. Considering any of the 3 biomarker classes as a positive, resulted in a sensitivity of 92% and specificity of 86%. Mutation analysis did not add sensitivity to the combination of analysis of copy number and methylation. This study demonstrates a proof-of-principle for non-invasive yet precise detection of endometrial cancer. We propose that with improved biomarker testing, it may be possible to develop a clinically useful test for detecting EC.

Endometrial Cancer

Linked Investigators

Chen Wang

Postdoctoral Associate of Stephenson School of Biomedical Engineering, University of Oklahoma