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

ACTION HIV (Anal Cancer TherapIes and Outcomes iNitiative for Patients Living With and Without HIV): A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05328765

Acronym

ACTION HIV

Enrollment

369

Registered

2022-04-14

Start date

2023-06-09

Completion date

2025-02-07

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Squamous Cell Carcinoma, HIV Infections

Keywords

HIV Infections, Anal Squamous Cell Carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Argentina, Brazil, Mexico, Peru, Uruguay

Contacts

PRINCIPAL_INVESTIGATORRachel Riechelmann

Brazilian Group of Gastrointestinal Tumors

Outcome results