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NCT Number: NCT05328765

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

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.

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Key information

Conditions

Anal Squamous Cell Carcinoma Anus Diseases Anus Neoplasms Blood-Borne Infections Colorectal Neoplasms Communicable Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Intestinal Neoplasms Lentivirus Infections Neoplasms Neoplasms by Site RNA Virus Infections Rectal Diseases Rectal Neoplasms Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.C. Camargo Cancer Center

São Paulo, 01509-001, Brazil

Location status: Recruiting

Location contact

Marcos Camandaroba

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Median disease-free survival

    Time frame: 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

  2. Complete clinical response

    Time frame: 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

  3. Overall survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Voelcker

CONTACT

[email protected]

+55 51 3384 5334

Viviane Horn de Melo

CONTACT

[email protected]

+55 51 3384 5334

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Registry information

Official study title

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

Acronym: ACTION HIV

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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