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NCT05257057 · ClinicalTrials.gov registry record
Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome
A clinical trial, sponsored by WellSpan Health.
- Completed
- Registry status
- 91
- Enrollment target
NCT05257057: Completed study, sponsored by WellSpan Health.
NCT05257057 is a clinical trial that has completed, run by WellSpan Health. The registered enrollment target is 91 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05257057 has completed, sponsored by WellSpan Health.
- COMPLETED
- Registry status
- 91 participants
- Enrollment target
Study Summary
Given that there is a significant prevalence of Lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endometrial intraepithelial neoplasia), it is hypothesized that a diagnosis of endometrial hyperplasia may herald on-going risk of harboring a Lynch Syndrome gene mutation. The purpose of this study is to examine endometrial hyperplasia specimens and compare the frequency of Lynch Syndrome gene mutations between endometrial hyperplasia and endometrial cancer subjects. This will provide a rationale and opportunity for earlier screening, and reduce colon cancer morbidity and mortality secondary to the Lynch syndrome gene.
Primary Outcome
This is the rate of subjects who screen positive for Lynch Syndrome based on immunohistochemical staining
Interventions
- DIAGNOSTIC_TEST Immunohistochemical staining
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2023-06-02 |
What the finished NCT05257057 record still lists
NCT05257057 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 91 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Immunohistochemical staining is the first listed.
NCT05257057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05257057 about?
NCT05257057 is a clinical study titled "Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome". Given that there is a significant prevalence of Lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endomet...
What is the current status of trial NCT05257057?
This trial is currently completed. The enrollment target is 91 participants. The study started on 2019-05-08. Estimated completion is 2023-06-02.
What interventions are being tested in trial NCT05257057?
The interventions under investigation include: Immunohistochemical staining (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05257057?
This trial is sponsored by WellSpan Health, which has 21 total clinical trials registered on ClinicalTrials.gov.
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