Endometrial Cell Collection With the PadKit

Neoplasms Clinical Trial

Official title:

Endometrial Cancer Cell Collection With the Preprogen PadKit™

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464107
• Other study ID #: Pro2023-0428
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: June 2024
• Source: Hackensack Meridian Health
• Contact: Diane Russomanno
• Phone: 7327762421
• Email: diane.russomanno[@]hmhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms

Intervention

Device:
• PadKit™ from Preprogen
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.

Locations

Country	Name	City	State
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Riverview Medical Center	Red Bank	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack Meridian Health	Preprogen

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Within the same day and after wearing the pad for 4-6 hours
Secondary	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.	Within the same day and after wearing the pad for 4-6 hours