Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study (EP48 HIV CHEST)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study|
- the prevalence of lung cancers detected by lowdose computed tomography [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
- the types of lung cancers in this population, [ Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26 ] [ Designated as safety issue: No ]
- the staging of non small cell lung cancers, [ Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26 ] [ Designated as safety issue: No ]
- description of risk factors for all lung cancers, [ Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26 ] [ Designated as safety issue: No ]
- number of complications of diagnosis procedures during study [ Time Frame: Month 1 Month 3 Month 12 Month 24 Month 26 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207986
|Montpellier, France, 34|
|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|