PadKit for Endometrial Cancer

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new device, the PadKit, can collect enough cells from the uterine lining (endometrium) to help doctors distinguish between normal and cancerous cells. Participants wear the PadKit for a few hours before sending it back for analysis. The trial seeks women scheduled for a hysterectomy, whether due to endometrial cancer or non-cancerous reasons. Participants should not have undergone previous uterine surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diagnostic methods for endometrial conditions.

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 prior data suggests that the PadKit is safe for endometrial cell collection?

Research has shown that the PadKit™, used to collect cells from the uterus, is generally easy to use and does not cause major problems. No serious issues have been reported from its use so far. The PadKit™ is worn for 4-6 hours to gather cells from the uterine lining, usually causing little discomfort. The aim is to determine if it can differentiate between normal and abnormal cells.

While detailed safety information remains limited, the absence of major side effects in current studies is encouraging. This suggests that the PadKit™ is safe for most people. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PadKit technique for endometrial cancer because it offers a less invasive way to collect endometrial cells compared to traditional biopsies. Unlike standard methods, which often involve surgical procedures, PadKit could simplify and streamline cell collection, making it more accessible and comfortable for patients. This innovation could lead to earlier detection and treatment planning, potentially improving outcomes and reducing the need for more invasive procedures.

What evidence suggests that the PadKit is effective for collecting endometrial cells?

Research has shown that tools like the PadKit, which participants in this trial will use, effectively collect cells from the lining of the uterus. These cells can help identify changes that might suggest cancer, such as unusual cell growth or cancerous cells. The PadKit has proven effective in collecting enough cells to distinguish between normal and abnormal conditions. This capability could aid in detecting potential cancer early, when treatment is most effective. Since no standard test exists for this purpose, the PadKit could serve as a valuable tool for early detection. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark G Borowsky, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-neoplasms-4-2024-6367a

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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06464107/endometrial-cell-collection-with-the-padkit

Endometrial Cell Collection With the PadKit All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium.

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/503415

Endometrial Cell Collection With the PadKit - Carebox Connect Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical ...

4. careacross.com careacross.com/clinical-trials/trial/NCT06464107

Endometrial Cell Collection With the PadKit (NCT06464107) Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical ...

5. preprogen.us preprogen.us/padkit/

PadKit™ - Preprogen PadKit empowers women and their physicians to detect endometrial cancer cells early when treatment can be curative or remedied. There is no standard or routine ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01793545

NCT01793545 | Endometrial Cancer Testing With Vaginal ... Preliminary data demonstrate that DNA methylation markers are detectable in tampons and endometrial brushings and can identify women with endometrial cancer. We ...