Screening for Lung Cancer in the HIV Patient

NCT ID: NCT01748136

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-09-30

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:

Conditions

Lung Cancer in the HIV Patient; HIV Infections; HIV Seropositivity; Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Arm

CT Scan Arm

CT Scan with Spirometry

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Brock, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

NA_00036809

Identifier Type: OTHER

Identifier Source: secondary_id

J0491

Identifier Type: -

Identifier Source: org_study_id