Screening for Lung Cancer in the HIV Patient (NA_00036809)

Johns Hopkins Medicine

Status: Completed

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

Treatments: Device: CT Scan with Spirometry

Study type: Observational

Funder types: Other

Identifiers

NCT01748136

NA_00036809 (Other Identifier)

J0491

Details and patient eligibility

About

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.

Full 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:

Enrollment: 200 patients

Sex: All

Ages: 26 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

200 participants in 1 patient group

Single Arm

Description:

CT Scan Arm

Treatment:

Device: CT Scan with Spirometry