Endometrial Cell Collection With the PadKit

NCT06464107 | Completed FDA Device

• 1 other identifier: Pro2023-0428
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neoplasms

Keywords

endometrial cancer; endometrial hyperplasia; neoplasms; atypical endometrial hyperplasia; Endometrial cells; interlabial pad

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Within 7 days after receipt of the pad from patients

Secondary Outcomes (2)

• Patient preferences - Comfort

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

• Patient preferences - Simplicity of using the pad

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

Study Arms (2)

Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy

EXPERIMENTAL

Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy

Device: PadKit™ from Preprogen

Benign clinical indications

EXPERIMENTAL

Women with planned hysterectomy for benign clinical indications

Device: PadKit™ from Preprogen

Interventions

PadKit™ from Preprogen DEVICE

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.

Benign clinical indications; Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Preprogen: collaborator

Study Sites (2)

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Related Publications (6)

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

  BACKGROUND

• 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.

  PMID: 31287423 BACKGROUND

• 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.

  PMID: 16633242 BACKGROUND

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

  PMID: 33207095 BACKGROUND

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

  PMID: 35673697 BACKGROUND

• 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.

  PMID: 31787246 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mark G Borowsky, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 18, 2024
• Study Start: May 31, 2024
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)