Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-05-31
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
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.
Benign clinical indications
Women with planned hysterectomy for benign clinical indications
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.
2. Cohort 2: women with planned hysterectomy for benign clinical indications
Exclusion Criteria
2. Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).
18 Years
FEMALE
No
Sponsors
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Preprogen
UNKNOWN
Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Mark G Borowsky, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Riverview Medical Center
Red Bank, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Lu KH, Broaddus RR. Endometrial Cancer. N Engl J Med. 2020 Nov 19;383(21):2053-2064. doi: 10.1056/NEJMra1514010. No abstract available.
Pangarkar MA. The Bethesda System for reporting cervical cytology. Cytojournal. 2022 Apr 30;19:28. doi: 10.25259/CMAS_03_07_2021. eCollection 2022.
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.
Other Identifiers
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Pro2023-0428
Identifier Type: -
Identifier Source: org_study_id
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