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| Name | Class |
|---|---|
| Preprogen | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy | Experimental | Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy |
|
| Benign clinical indications | Experimental | Women with planned hysterectomy for benign clinical indications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
1. Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark G Borowsky, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States | ||
| Riverview Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Cancer Society Endometrial Cancer Statistics. Retrieved from : https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.html | ||
| 31287423 | 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. | |
| 16633242 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 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 |
| Red Bank |
| New Jersey |
| 07701 |
| United States |
| 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. |
| 33207095 | 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. |
| 35673697 | 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. |
| 31787246 | 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. |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |