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Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

NCT01164722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-08-04

Study results available
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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.

Conditions

  • Anal Cancer
  • Neoplasm of Uncertain Malignant Potential
  • Nonneoplastic Condition
  • Precancerous Condition

Interventions

OTHER

clinical observation

Patients undergo observation

DEVICE

infrared photocoagulation therapy

Anal infrared coagulator ablation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of Arkansas

    collaborator OTHER

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Stephen E. Goldstone, MD · Laser Surgery Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
27 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164722 on ClinicalTrials.gov