Clinical trial NCT06464107: Endometrial Cell Collection With the PadKit
Official title: Endometrial Cancer Cell Collection With the Preprogen PadKit™
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: endometrial cancer
endometrial hyperplasia
neoplasms
atypical endometrial hyperplasia
Endometrial cells
interlabial pad
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Preprogen
First posted: 2024-06-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Observation of the presence of endometrial cells captured by the pad.
timeFrame: Within 7 days after receipt of the pad from patients
measure: Association of the presence/absence of cells and morphology
timeFrame: Within 7 days after receipt of the pad from patients
Secondary outcomes:
measure: Patient preferences - Comfort
timeFrame: Within the same day and after wearing the pad for 4-6 hours
measure: Patient preferences - Simplicity of using the pad
timeFrame: Within the same day and after wearing the pad for 4-6 hours
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Mark G Borowsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Cancer Society Endometrial Cancer Statistics. Retrieved from : https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.html
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.
citation: 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.
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.
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.
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.