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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01207986
First received: September 16, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Hiv Infection
Lung Cancer
Radiation: Low dose computed tomography (CT)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • the prevalence of lung cancers detected by lowdose computed tomography [ Time Frame: Month 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Low dose computed tomography (CT)
    .
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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207986

Locations
France
Makinson
Montpellier, France, 34
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01207986     History of Changes
Other Study ID Numbers: AO 781-38
Study First Received: September 16, 2010
Last Updated: September 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lung Neoplasms
HIV Infections
Acquired Immunodeficiency Syndrome
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014