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NCT02420665 · ClinicalTrials.gov registry record · Early Phase 1
Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT02420665: Completed Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02420665 is a Early Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02420665, a Early Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
Primary Outcome
To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis. That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy. Target concordance rate is 70%. Concordance
Interventions
- PROCEDURE Colposcopy
- DRUG Proflavine
- BEHAVIORAL Phone Call
- DEVICE HRME Imaging
- DRUG Acetic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-09-23 |
| Est. Completion | 2021-05-14 |
| Phase | Early Phase 1 |
What the finished NCT02420665 record still lists
NCT02420665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Colposcopy is the first listed.
NCT02420665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02420665 about?
NCT02420665 is a clinical study titled "Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia". The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if ...
What is the current status of trial NCT02420665?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2015-09-23. Estimated completion is 2021-05-14.
What interventions are being tested in trial NCT02420665?
The interventions under investigation include: Colposcopy (PROCEDURE), Proflavine (DRUG), Phone Call (BEHAVIORAL), HRME Imaging (DEVICE), Acetic Acid (DRUG).
Who is sponsoring clinical trial NCT02420665?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02420665's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,468 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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