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

HIV Infections Clinical Trial

— ACTION HIV  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328765
• Other study ID #: LACOG 0421
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Latin American Cooperative Oncology Group
• Contact: Laura Mendonça Diefenthäeler
• Phone: +55 51 3384 5334
• Email: laura.mendonca[@]lacogcancerresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Anal Squamous Cell Carcinoma
• Anus Neoplasms
• Carcinoma
• Carcinoma, Squamous Cell
• Communicable Diseases
• HIV Infections
• Infections

Locations

Country	Name	City	State
Brazil	A.C. Camargo Cancer Center	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median disease-free survival	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	3 years
Primary	Complete clinical response	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	6 months
Primary	Overall survival	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.	From first date of treatment to date of death from any cause, assessed up to 3 years.