Screening for Lung Cancer in the HIV Patient

Completed

• Conditions: HIV Seropositivity; Lung Cancer; Lung Cancer in the HIV Patient; HIV Infections
• Interventions: Device: CT Scan with Spirometry

• Registration Number: NCT01748136
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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.

Detailed Description

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:

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	CT Scan with Spirometry	CT Scan Arm

Primary Outcome Measures

Name	Time	Method
Stage distribution of HIV-seropositive patients	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
To create a specimen bank of serum, sputum, and tissue	5 years	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.