NCT01207986

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 23, 2026

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

September 16, 2010

Last Update Submit

April 21, 2026

Conditions

Hiv InfectionLung Cancer

Outcome Measures

Primary Outcomes (1)

  • the prevalence of lung cancers detected by lowdose computed tomography

    Month 0

Secondary Outcomes (4)

  • the types of lung cancers in this population,

    Month 1 Month 3 Month 12 Month 24 Month 26

  • the staging of non small cell lung cancers,

    Month 1 Month 3 Month 12 Month 24 Month 26

  • description of risk factors for all lung cancers,

    Month 1 Month 3 Month 12 Month 24 Month 26

  • number of complications of diagnosis procedures during study

    Month 1 Month 3 Month 12 Month 24 Month 26

Study Arms (1)

CT screening

OTHER

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)

Interventions

Low dose computed tomography (CT)RADIATION
CT screening

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makinson

Montpellier, 34, France

Location

Related Publications (1)

  • Makinson A, Eymard-Duvernay S, Raffi F, Abgrall S, Bommart S, Zucman D, Valour F, Cheret A, Poizot-Martin I, Duvivier C, Mauboussin JM, Bonnet F, Tattevin P, Reynes J, Le Moing V; ANRS EP48 HIV CHEST study Team. Feasibility and efficacy of early lung cancer diagnosis with chest computed tomography in HIV-infected smokers. AIDS. 2016 Feb 20;30(4):573-82. doi: 10.1097/QAD.0000000000000943.

    PMID: 26829006RESULT

Related Links

MeSH Terms

Conditions

HIV InfectionsLung Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 23, 2010

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2014

Last Updated

April 23, 2026

Record last verified: 2015-07

Locations

FR(1)