Clinical trial · Interventional
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study
NCT00066430CI-TRIAL-00015630completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer in patients who have anal neoplasia. PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infrared Coagulator | Device | — | UNRESOLVED |
| infrared photocoagulation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Infrared coagulator
- interventionNames
- Procedure: infrared photocoagulation therapy
- Device: Infrared Coagulator
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * HIV positive * Presence of internal anal lesions with histologically confirmed high-grade squamous intraepithelial neoplasia with at least 1 positive margin * No more than 3 lesions, each no more than 10 mm in diameter * No evidence of microscopic invasion in any anal biopsy specimens * No history of anal cancer PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Platelet count at least 50,000/mm\^3 * CD4 count at least 50 cells/mm\^3 Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to lidocaine * No anal insertions, including enemas or anal intercourse, for 24 hours before and at least 1 week after study treatment * No prior severe photosensitivity reaction * No active opportunistic infection * No concurrent neoplasia requiring cytotoxic therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Must be on stable regimen of highly active antiretroviral therapy (HAART) for at least 12 weeks prior to study entry unless CD4 count \> 200/mm\^3 AND no plans to initiate HAART within the next 3 months * More than 14 days since prior acute treatment for an infection or other medical illness * No prior infrared coagulation for anal dysplasia
References
Publications (0)
Data not yet available
No reference posted for this study.