Pilot study of Anal Neoplasia Treatment in people with HIV Evaluation and monitoring (short title: PANTHER)

niversity of New South Wales Sydney, NSW, Australia0 个研究点目标入组 100 人开始时间: 2024年2月16日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•1.Aged 18 years or older
•2.Documented HIV positive
•3.Current patient of the Dysplasia and Anal Cancer Services (DACS) clinic under active follow-up
•4. Histologically established persistent intra-anal HSIL of 4 or fewer octants diagnosed on 2 or more occasions, OR intra-anal HSIL considered by study doctor to be eligible for treatment
•5.Willing to not undergo any other anal HSIL therapeutic interventions while taking part in the study. Treatment for anal conditions other than HSIL (such as dermatological abnormalities) may be allowed with the permission of the study doctor.
•6. Able to provide written informed consent
•7.No planned absences during the first 6 months of follow-up.

•1.History of any other HSIL treatment within 3 months prior to the Baseline visit
•2.Any perianal HSIL diagnosed, alone or in conjunction with intra-anal HSIL
•3.Substantial quantity of anal verge HSIL subject to clinicians’ discretion
•4. Intra-anal exophytic low-grade lesions, the extent of which compromises the ability to deliver effective electrocautery
•5. Any anal or rectal pathology such as ulcer, fistula, stricture, or stenosis that, in the clinician’s assessment, is likely to adversely affect the efficacy of treatment
•6.Concurrent malignancy requiring systemic therapy
•7. At the clinician’s discretion, whether the participant is on a platelet inhibiting agent (e.g., Clopidogrel) and/or anti-thrombotic agent (e.g., Heparin or Rivaroxaban) and unable to discontinue 7 days before and after treatment for 14 days total.
•oException: Aspirin 100 mg PO daily does not need to be discontinued
•8.Undergoing Warfarin therapy
•9.Pregnant or planning to become pregnant during the treatment period
•10.Unwilling to comply with study-related procedures
•11.Unable to undergo or tolerate the HRA procedure.
•12. Has a pacemaker.

发起方

niversity of New South Wales Sydney, NSW, Australia