A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLatin American Cooperative Oncology Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of data on treatments and clinical outcomes
Trial population
Potentially eligible patients will be screened through the administrative lists of participating centres. Based on convenience and viability, we estimate to accumulate 300 patients with CCA with and without HIV infection.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: With HIV Infection
Group B: Without HIV Infection
Trial outcomes
Primary outcomes
1
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
Time frame
3 years2
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
Time frame
6 months3
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.
Time frame
From first date of treatment to date of death from any cause, assessed up to 3 years.Sponsors and contacts
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Source ClinicalTrials.gov