Neoplasms
Conditions
Keywords
endometrial cancer, endometrial hyperplasia, neoplasms, atypical endometrial hyperplasia, Endometrial cells, interlabial pad
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.
Interventions
DEVICEPadKit™ 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.
Sponsors
Hackensack Meridian Health
Preprogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association of the presence/absence of cells and morphology | Within 7 days after receipt of the pad from patients | Analysis for the presence of abnormal histology and morphological classification as normal, hyperplastic, or malignant. |
| Observation of the presence of endometrial cells captured by the pad. | Within 7 days after receipt of the pad from patients | Direct observation of the absence or presence of endometrial cells on the pad by the pathologist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient preferences - Comfort | Within the same day and after wearing the pad for 4-6 hours | 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. |
| Patient preferences - Simplicity of using the pad | Within the same day and after wearing the pad for 4-6 hours | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark G Borowsky, MD
Hackensack Meridian Health
Outcome results
None listed