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NeoplasmsNCT06464107

Endometrial Cell Collection With the PadKit

A study testing PadKit™ from Preprogen in people with Neoplasms, run by Hackensack Meridian Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms
What is being tested?
PadKit™ from Preprogen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
31 May 2024to 17 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 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.
  • Cohort 2: women with planned hysterectomy for benign clinical indications

Who cannot join

  • Unable to provide informed consent
  • Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Riverview Medical Center

    Red Bank, New Jersey, 07701

Other trials in United States

About this study

Official title: Endometrial Cancer Cell Collection With the Preprogen PadKit™

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.

Conditions
Neoplasms
Being tested
PadKit™ from Preprogen
Keywords
endometrial cancer, endometrial hyperplasia, neoplasms, atypical endometrial hyperplasia, Endometrial cells, interlabial pad
Medical subject headings
Neoplasms, Endometrial Neoplasms, Endometrial Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PadKit™ from PreprogenDevice

    The interlabial pad is classified as a Class 1 device by the FDA and the device is exempt from requiring a 510(k) approval.

    The interlabial pad is worn for 4-6 consecutive hours and collects cells shed from the cervix and uterine cavity. The pad is then removed and placed in the smaller, inner tube that contains the transport solution. After replacing the lid securely, it is then carefully placed back inside the larger outer tube with the outer lid secured and returned to the original box. The entire box is placed in the polybag and mailed back to the lab for analysis.

Study groups in NCT06464107
Study groupRoleWhat they receive
Biopsy proven hyperplasia/endometrial cancer with planned hysterectomyExperimentalWomen with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
Receives: Device: PadKit™ from Preprogen
Benign clinical indicationsExperimentalWomen with planned hysterectomy for benign clinical indications
Receives: Device: PadKit™ from Preprogen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 7 days after receipt of the pad from patients

  2. Association of the presence/absence of cells and morphology

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

    Measured: Within 7 days after receipt of the pad from patients

Secondary outcomes (2)

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start31 May 2024
  3. Primary completion17 Apr 2026
  4. Study completion17 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464107
Sponsor's protocol ID
Pro2023-0428
Status last verified
May 2026
First submitted
6 Jun 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • American Cancer Society Endometrial Cancer Statistics. Retrieved from : https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.html

  • Hinson S, Molberg K, Mir M, Flores M, Zheng W, Lucas E. Age cutoff for reporting of benign-appearing endometrial cells in Papanicolaou specimens; should it be raised? A 10-year retrospective study from a large county hospital. J Am Soc Cytopathol. 2019 Mar-Apr;8(2):78-83. doi: 10.1016/j.jasc.2018.09.002. Epub 2018 Sep 11.

    PubMed 31287423

  • Greenspan DL, Cardillo M, Davey DD, Heller DS, Moriarty AT. Endometrial cells in cervical cytology: review of cytological features and clinical assessment. J Low Genit Tract Dis. 2006 Apr;10(2):111-22. doi: 10.1097/01.lgt.0000210130.01016.ad.

    PubMed 16633242

  • Lu KH, Broaddus RR. Endometrial Cancer. N Engl J Med. 2020 Nov 19;383(21):2053-2064. doi: 10.1056/NEJMra1514010. No abstract available.

    PubMed 33207095

  • Pangarkar MA. The Bethesda System for reporting cervical cytology. Cytojournal. 2022 Apr 30;19:28. doi: 10.25259/CMAS_03_07_2021. eCollection 2022.

    PubMed 35673697

  • Sangtani A, Wang C, Weaver A, Hoppman NL, Kerr SE, Abyzov A, Shridhar V, Staub J, Kocher JA, Voss JS, Podratz KC, Wentzensen N, Kisiel JB, Sherman ME, Bakkum-Gamez JN. Combining copy number, methylation markers, and mutations as a panel for endometrial cancer detection via intravaginal tampon collection. Gynecol Oncol. 2020 Feb;156(2):387-392. doi: 10.1016/j.ygyno.2019.11.028. Epub 2019 Nov 28.

    PubMed 31787246

Questions about this trial

What is this clinical trial studying?

A study testing PadKit™ from Preprogen in people with Neoplasms, run by Hackensack Meridian Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observation of the presence of endometrial cells captured by the pad. (time frame: Within 7 days after receipt of the pad from patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06464107, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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Endometrial Cell Collection With the PadKit | AzTrials