History of Changes for Study: NCT05328765

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

Latest version (submitted June 20, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	April 13, 2022	None (earliest Version on record)
2	July 25, 2022	Study Status
3	September 26, 2022	Study Status
4	November 28, 2022	Study Status
5	February 27, 2023	Study Status
6	June 20, 2023	Recruitment Status, Study Status, Contacts/Locations and Oversight

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Study NCT05328765
Submitted Date: April 13, 2022 (v1)

Study Identification


Unique Protocol ID:	LACOG 0421
Brief Title:	A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection (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
Secondary IDs:

Study Status


Record Verification:	April 2022
Overall Status:	Not yet recruiting
Study Start:	May 31, 2022
Primary Completion:	November 30, 2023 [Anticipated]
Study Completion:	February 1, 2024 [Anticipated]

First Submitted:	April 5, 2022
First Submitted that Met QC Criteria:	April 13, 2022
First Posted:	April 14, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	April 13, 2022
Last Update Posted:	April 14, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Latin American Cooperative Oncology Group
Responsible Party:	Sponsor
Collaborators:

Study Description

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:

Conditions


Conditions:	Anal Squamous Cell Carcinoma HIV Infections
Keywords:	HIV Infections Anal Squamous Cell Carcinoma

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Retrospective
Biospecimen Retention:	None Retained
Biospecimen Description:	We will also note whether tumor tissue is available from pre-treatment biopsy at the participating center to plan future translational studies.
Enrollment:	300 [Anticipated]
Number of Groups/Cohorts	2

Groups and Interventions

Groups/Cohorts	Interventions
With HIV Infection Patients with CCA with HIV infection,
Without HIV Infection Patients with CCA without HIV infection,

Outcome Measures


Primary Outcome Measures:
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.

Eligibility


Study 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.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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

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