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

Primary Purpose

Hiv Infection, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low dose computed tomography (CT)
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hiv Infection

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makinson

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CT screening

Arm Description

CT interpretations and lung biopsies are guided by a suggested workup algorithm, which is not imposed in each HIV-caring centre

Outcomes

Primary Outcome Measures

the prevalence of lung cancers detected by lowdose computed tomography

Secondary Outcome Measures

the types of lung cancers in this population,
the staging of non small cell lung cancers,
description of risk factors for all lung cancers,
number of complications of diagnosis procedures during study

Full Information

First Posted
September 16, 2010
Last Updated
July 17, 2015
Sponsor
ANRS, Emerging Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT01207986
Brief Title
Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv Infection, Lung Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT screening
Arm Type
Other
Arm Description
CT interpretations and lung biopsies are guided by a suggested workup algorithm, which is not imposed in each HIV-caring centre
Intervention Type
Radiation
Intervention Name(s)
Low dose computed tomography (CT)
Primary Outcome Measure Information:
Title
the prevalence of lung cancers detected by lowdose computed tomography
Time Frame
Month 0
Secondary Outcome Measure Information:
Title
the types of lung cancers in this population,
Time Frame
Month 1 Month 3 Month 12 Month 24 Month 26
Title
the staging of non small cell lung cancers,
Time Frame
Month 1 Month 3 Month 12 Month 24 Month 26
Title
description of risk factors for all lung cancers,
Time Frame
Month 1 Month 3 Month 12 Month 24 Month 26
Title
number of complications of diagnosis procedures during study
Time Frame
Month 1 Month 3 Month 12 Month 24 Month 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Makinson
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine Cheret
Organizational Affiliation
CHU Tourcoing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie Abgrall
Organizational Affiliation
Hospital Avicenne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Delamonicca
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Tattevin
Organizational Affiliation
Pontchaillou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle Poizot Martin
Organizational Affiliation
St Marguerite Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francois Raffi
Organizational Affiliation
Hotel Dieu Nantes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudine Duvivier
Organizational Affiliation
Necker Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Zucman
Organizational Affiliation
Foch Suresnes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Louis Couderc
Organizational Affiliation
Foch Suresnes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tristan Ferry
Organizational Affiliation
La Croix Rousse Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Marc Mauboussin
Organizational Affiliation
Nîmes, CH Caremeau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makinson
City
Montpellier
ZIP/Postal Code
34
Country
France

12. IPD Sharing Statement

Links:
URL
http://anrs.fr
Description
Related Info

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

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