Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study
Condition: Hiv Infection; Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Low dose computed tomography (CT)
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening