Clinical trial · Interventional
Endometrial Cell Collection With the PadKit
Endometrial Cancer Cell Collection With the Preprogen PadKit™
NCT06464107CI-TRIAL-00111382completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PadKit™ from Preprogen | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
- description
- Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
- interventionNames
- Device: PadKit™ from Preprogen
- type
- EXPERIMENTAL
- label
- Benign clinical indications
- description
- Women with planned hysterectomy for benign clinical indications
- interventionNames
- Device: PadKit™ from Preprogen
Primary outcomes (2)
- measure
- Observation of the presence of endometrial cells captured by the pad.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (6)
- BACKGROUNDAmerican Cancer Society Endometrial Cancer Statistics. Retrieved from : https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.html
- BACKGROUNDHinson 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
- BACKGROUNDGreenspan 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
- BACKGROUNDLu 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
- BACKGROUNDPangarkar 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
- BACKGROUNDSangtani 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