PadKit for Endometrial Cancer

Recruiting at 1 trial location

Overseen By Danielle Kwiatkowski

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Prior uterine surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PadKit for Endometrial Cancer?

Research suggests that endometrial sampling devices, like those used in PadKit, can be effective for collecting cells to monitor endometrial cancer, which may help in early detection and treatment planning. ^{1 2 3 4 5}

Research Team

Mark G Borowsky, MD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

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.

Inclusion Criteria

I am a woman seeing a specialist for surgery and have not had my uterus removed.

I have a biopsy showing atypical hyperplasia or endometrial cancer.

I am a woman scheduled for a hysterectomy for non-cancer reasons.

Exclusion Criteria

I am unable to understand or sign the consent form.

I have had surgery on my uterus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Cell Collection

Participants wear the Preprogen Pad for 4-6 hours to collect endometrial cells

1 day

1 visit (in-person)

Analysis

Analysis of the collected cells to determine if the PadKit™ can differentiate between normal and atypical hyperplasia/malignant cells

Within 7 days after receipt of the pad

Follow-up

Participants are monitored for feedback on comfort and simplicity of using the PadKit™

1 day

Survey completion

Treatment Details

Interventions

• Endometrial Cell Collection with PadKit

Trial Overview 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.

Participant Groups

Group I: Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy Experimental Treatment 1 Intervention

Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy

Group II: Benign clinical indications Experimental Treatment 1 Intervention

Women with planned hysterectomy for benign clinical indications

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Preprogen

Collaborator

Trials

1

Recruited

80+

Findings from Research

The endometrial sampling device proved to be a feasible tool for monitoring patients with endometrial cancer or atypical hyperplasia during follow-up visits, achieving a high sampling success rate of 95% in 43 procedures across 19 patients.

Histological results from the endometrial sampling device were comparable to those obtained through hysteroscopy in cases with thicker endometrial linings, indicating its effectiveness, although caution is advised for patients with thinner endometria, where results may differ.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of endometrial sampling device during the follow-up visit for the conservative treatment of endometrial cancer]. Zhou, R., Shen, DH., Wang, CH., et al.[2014]

In a study of 20 premenopausal patients with endometrial cancer or atypical endometrial hyperplasia, those with copy number-low (CN-L) tumors showed the best response to progesterone treatment, with 62% achieving complete response, while microsatellite instability-high (MSI-H) tumors had the poorest outcomes.

Recurrence after achieving complete response was common, occurring in 40% of patients, highlighting the need for close monitoring and suggesting that molecular subtype may play a significant role in treatment response and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular subtyping in endometrial cancer: A promising strategy to guide fertility preservation. Dagher, C., Manning-Geist, B., Ellenson, LH., et al.[2023]

Endometrial cytology using the Endoflower device demonstrated 100% accuracy in detecting endometrial cancer, making it a reliable alternative to traditional biopsy methods.

The study found that evaluating PTEN expression in endometrial samples can help identify patients who may benefit from targeted therapies, highlighting the potential for these cytology techniques to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of PTEN in endometrial liquid-based cytology. Di Lorito, A., Zappacosta, R., Capanna, S., et al.[2016]

A systematic review of 45 studies involving 12,459 patients found only moderate agreement (67%) between preoperative endometrial sampling and final tumor grade diagnosis, indicating potential discrepancies in cancer grading.

Hysteroscopic biopsy showed the highest agreement rate (89%) with final diagnoses compared to other sampling methods, while the lowest agreement was observed for grade 2 carcinomas, highlighting the need for careful interpretation of preoperative results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis. Visser, NCM., Reijnen, C., Massuger, LFAG., et al.[2022]

UterCAD, a non-invasive test using tampon-collected specimens, demonstrated high sensitivity (83.3%) and specificity (92.9%) for detecting endometrial carcinoma (EC) in a study of 51 patients with abnormal bleeding.

The test successfully identified chromosomal abnormalities in 83.3% of EC cases, including all cases of uterine serous carcinoma, suggesting it could help avoid invasive procedures like hysteroscopic biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-coverage whole-genome sequencing for the effective diagnosis of early endometrial cancer: A pilot study. Qiu, H., Wang, M., Cao, T., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

[Application of endometrial sampling device during the follow-up visit for the conservative treatment of endometrial cancer]. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Molecular subtyping in endometrial cancer: A promising strategy to guide fertility preservation. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Expression of PTEN in endometrial liquid-based cytology. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Low-coverage whole-genome sequencing for the effective diagnosis of early endometrial cancer: A pilot study. [2023]