Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study (EP48 HIV CHEST)

April 21, 2026 updated by: ANRS, Emerging Infectious Diseases
Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography (CT) in a HIV-infected population with an important smoking history. Other objectives are (1) the evaluation of the types of lung cancers in this population, as well as (2) the staging of non small cell lung cancers, (3) the description of risk factors for all lung cancers, if they are numerous enough, and (4) the number of complications of diagnosis procedures during the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Epidemiological studies in France and in the western world have shown that lung cancers are the first cause of mortality amongst the non-AIDS classifying cancers in HIV-infected individuals, despite the introduction of combination antiretroviral therapies. Compared to the general population, there is an increased risk of lung cancer in HIV-infected individuals, even after adjustment on smoking and age, estimated to be around 2.6 compared to the general population. Outcomes are dismal, as diagnoses in HIV-infected individuals are usually made at very advanced stages (usually stage III or IV) without screening. Two non-randomized studies of CT-screening in a non HIV-infected population exposed to smoking have shown an important rate of early lung cancer detection and a high level of survival at 5 or 10 years. Despite a probable high prevalence of lung cancer in the HIV-infected population, no lung cancer screening or early diagnosis studies have been realised, and the prevalence is yet to be determined. We deduced from different studies of non HIV-infected populations a 3% prevalence in the HIV-infected population.

Methods Prospective multicentric and national study evaluating the prevalence of lung cancers through low-dose CT of 450 individuals with a known HIV-infection, with a nadir level of TCD4 cells < 350/µl, ≥ 40 years old and with a smoking history ≥ 20 packs a year (either active or with <3 years of weaning). CT interpretations and lung biopsies are guided by a suggested workup algorithm, which is not imposed in each HIV-caring centre.

Inclusion and follow up period Inclusion period will be 9 months, followed, in case of the discovery of a small nodule, by a CT follow up scheme of up to two years from first diagnosis. The study closes after 26 months of follow up.

Awaited results For the first time, this prospective study of lung cancers will estimate the prevalence of these cancers screened in the HIV-infected population. Risks associated with the incidence of this cancer will be investigated, including potential immune factors. An increased number of stage I non small cell lung cancers are expected.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34
        • Makinson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 40 years
  • able to give written consent
  • HIV positive serology
  • Covered by French Social Security
  • Nadir L TCD4 < 350/µl
  • Rate of LTCD4 > 100/µl at inclusion
  • Addiction to smoking > 20 packages years, active person or deprived since < 3 years

Exclusion Criteria:

  • patients who suffered from comorbidity
  • unaffiliated to the social healthy security french system
  • Presence of an evolutionary cancer
  • any evolutionary pathology classifying AIDS
  • Pregnancy
  • Recent lung infection (< 2 months)
  • Be under protection (saving) of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CT screening
CT interpretations and lung biopsies are guided by a suggested workup algorithm, which is not imposed in each HIV-caring centre
Radiation: Low dose computed tomography (CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the prevalence of lung cancers detected by lowdose computed tomography
Time Frame: Month 0
Month 0

Secondary Outcome Measures

Outcome Measure
Time Frame
the types of lung cancers in this population,
Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26
Month 1 Month 3 Month 12 Month 24 Month 26
the staging of non small cell lung cancers,
Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26
Month 1 Month 3 Month 12 Month 24 Month 26
description of risk factors for all lung cancers,
Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26
Month 1 Month 3 Month 12 Month 24 Month 26
number of complications of diagnosis procedures during study
Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26
Month 1 Month 3 Month 12 Month 24 Month 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Alain Makinson, University Hospital, Montpellier
  • Principal Investigator: Antoine Cheret, CHU Tourcoing
  • Principal Investigator: Sophie Abgrall, Hospital AVICENNE
  • Principal Investigator: Pierre Delamonicca, CHU Nice
  • Principal Investigator: Pierre Tattevin, Pontchaillou
  • Principal Investigator: Isabelle Poizot Martin, St Marguerite Marseille
  • Principal Investigator: Francois Raffi, Hotel Dieu Nantes
  • Principal Investigator: Claudine Duvivier, Necker Paris
  • Principal Investigator: David Zucman, Foch Suresnes
  • Principal Investigator: Jean Louis Couderc, Foch Suresnes
  • Principal Investigator: Tristan Ferry, La Croix Rousse Lyon
  • Principal Investigator: Jean Marc Mauboussin, Nîmes, CH Caremeau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimated)

September 23, 2010

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AO 781-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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