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

Lung Cancer Clinical Trial

— EP48 HIV CHEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207986
• Other study ID #: AO 781-38
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: July 17, 2015
• Start date: February 2011
• Est. completion date: August 2014

Study information

• Verified date: July 2015
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Hiv Infection
• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Low dose computed tomography (CT)

Locations

Country	Name	City	State
France	Makinson	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prevalence of lung cancers detected by lowdose computed tomography		Month 0	No
Secondary	the types of lung cancers in this population,		Month 1 Month 3 Month 12 Month 24 Month 26	No
Secondary	the staging of non small cell lung cancers,		Month 1 Month 3 Month 12 Month 24 Month 26	No
Secondary	description of risk factors for all lung cancers,		Month 1 Month 3 Month 12 Month 24 Month 26	No
Secondary	number of complications of diagnosis procedures during study		Month 1 Month 3 Month 12 Month 24 Month 26	No

External Links

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