CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
clinical observation +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01164722
NCT01164722Phase 3Completed
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A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults

AIDS Malignancy Consortium·interventional·Posted Jul 19, 2010·Updated Aug 4, 2020

In Brief

A Phase 3 clinical trial evaluating clinical observation and infrared photocoagulation therapy for Anal Cancer and 3 related conditions. Completed, enrolled 120 participants across 7 sites.

Detailed Summary

RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how well it works compared to observation in preventing anal cancer in HIV-positive patients with anal neoplasia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Cancer, Neoplasm of Uncertain Malignant Potential, Nonneoplastic Condition, Precancerous Condition
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2010
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2015
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.0 years ago

Interventions

clinical observationother

Patients undergo observation

infrared photocoagulation therapydevice

Anal infrared coagulator ablation