Screening for Lung Cancer in the HIV Patient

Study Overview
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Brief Summary
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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
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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:

Official Title
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Screening for Lung Cancer in the HIV Patient

Conditions
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Lung Cancer in the HIV Patient, HIV Infections, HIV Seropositivity, Lung Cancer

Intervention / Treatment
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* Device: CT Scan with Spirometry


Participation Criteria
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Eligibility Criteria
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Age over 25 years old. Confirmed HIV seropositive by ELISA assay No woman who has a positive serum pregnancy Current or previous cumulative cigarette smoking history of > 20 pack years Former smokers must have quit smoking within the previous 15 years. No medical or psychiatric condition precluding informed medical consent. Ability to lie on the back with arms raised over the head. No metallic implants or metallic devices in the chest or back (pacemakers or Harrington rods, etc.) that would cause sufficient beam hardening artifact. No prior history of lung cancer. No prior removal of any portion of the lung, excluding percutaneous lung biopsy. No requirement for home oxygen supplementation for respiratory conditions. No participation in cancer prevention trials except smoking cessation programs No pneumonia or acute respiratory infection within 12 weeks of enrollment that was treated with antibiotics under physician supervision. No individuals within 6 months of receipt of cytotoxic agents for any condition. No chest CT scan within the preceding 6 months Signed study-specific informed consent prior to study entry.

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>CT Scan Arm | Device: CT Scan with Spirometry<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage distribution of HIV-seropositive patients | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To create a specimen bank of serum, sputum, and tissue | 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. | 5 years |