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 Overview

• Status: Completed
• Conditions: HIV Infections; Lung Cancer; HIV Seropositivity; Lung Cancer in the HIV Patient
• Intervention / Treatment: Device: CT Scan with Spirometry

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 Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-positive participants enrolled from the Johns Hopkins HIV (Moore) Clinic, as well as from the existing HIV-seropositive cohort of 800 patients (the Human Oral Papillomavirus Etiology (HOPE) Study).

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epigenetic analysis of sera and sputa	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.	4 weeks

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (ESTIMATE): December 12, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; HIV Infections; Lung Neoplasms; HIV Seropositivity
• Other Study ID Numbers: J0491; NA_00036809 (OTHER: JHMIRB)