A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection

Recruiting

• Conditions: HIV Infections; Anal Squamous Cell Carcinoma

• Registration Number: NCT05328765
• Lead Sponsor: Latin American Cooperative Oncology Group

Brief Summary

Due to the scarcity of data on prognostic and predictive influence on CCA, epidemiological studies evaluating these factors need to be developed in patients with CCA. Therefore, the investigators want to evaluate the profile of patients in the real world and from various parts of the world, describing prognostic factors such as CD4 dosage, time of HIV infection, evaluation of viral load, diagnosis of AIDS, geographic region of diagnosis and treatment, clinical staging, medications concomitant with QRT (risk of drug interactions), comorbidities (possible impact on dose-intensity), use of HAART, time of use of HAART, radiotherapy modality (conventional 3D vs Modulated Beam Intensity \[IMRT\], response to Nigro vs CTII regimens, as well as comparing clinical outcomes with patients without HIV infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2023-06-09
• Status Verified: 2024-07
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients 18 years of age or older
• Confirmed histological diagnosis of anal canal squamous cell carcinoma. Basaloid subtype is accepted
• Have underundered serological test for HIV infection
• Any clinical stage

Exclusion Criteria

• Lack of data on treatments and clinical outcomes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median disease-free survival	3 years	Defined as time from Day 1 from initiation of treatment (or definition of exclusive supportive care) to tumor death or recurrence. Disease-free survival at 3 years after initiation of treatment: proportion of patients free of local or metastatic disease at 3 years after treatment termination according to imaging tests (chest, abdomen and pelvis scans) and clinical examination of anal inspection
Complete clinical response	6 months	Absence of neoplasia on magnetic resonance imaging (preferred) or computed tomography of the pelvis and on clinical examination of anal inspection 6 months after the end of QRT or RT isolated
Overall survival	From first date of treatment to date of death from any cause, assessed up to 3 years.	Defined as the date from the D1 of treatment (or exclusive supportive care) to death from any cause; living patients at the time of the analysis will be censored.

Trial Locations

Locations (1)

A.C. Camargo Cancer Center; 🇧🇷 São Paulo, Brazil