Screening for Lung Cancer in the HIV Patient (NA_00036809)
That computed tomography (CT) screening of HIV-seropositive heavy smokers will detect early stage lung cancer at significantly higher rates than what is currently being observed.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Screening for Lung Cancer in the HIV Patient|
- Stage distribution of HIV-seropositive patients [ Time Frame: Day 1 ] [ Designated as safety issue: No ]To determine differences in stage distribution of HIV-seropositive patients at lung cancer diagnosis between those who are screened by spiral CT and historic controls.
- To create a specimen bank of serum, sputum, and tissue [ Time Frame: 5 years ] [ Designated as safety issue: No ]To create a specimen bank of serum, sputum, and tissue from the cohort of heavy smokers with HIV at high risk for lung cancer identified in Specific Aim 1.
- Epigenetic analysis of sera and sputa [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]To use epigenetic analysis of sera and sputa collected in Specific Aim 2 from patients screened in Specific Aim 1 as a complementary approach to low dose helical CT in order to discriminate radiologically indeterminate nodules as either molecularly positive or negative.
|Study Start Date:||January 2006|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
CT Scan Arm
Device: CT Scan with Spirometry
During the screening and later during the five annual study visits the patients will be scheduled to undergo total of five CT scans. The first CT scan will take place at the beginning of the study and then each year for a period of five years.
The study design is that of a prospective cohort study in which 200 smoking participants will be recruited from an existing HIV-seropositive cohort of 800 patients (the Human Oral Papillomavirus Etiology (HOPE) Study). Participants will be enrolled from the Johns Hopkins HIV (Moore) Clinic and the resources of the Johns Hopkins Adult Outpatient General Clinical Research Center (GCRC) and pilot project funding from the Lung Cancer SPORE will be utilized to fund the costs of the CT scans. An interdisciplinary team with expertise in HIV-associated malignancy, CT screening, lung cancer surgery, HIV infection, epidemiology and biostatistics has been assembled to test the hypothesis by accomplishing the following Specific Aims: