Screening for Lung Cancer in the HIV Patient
26 Years
N/A
Both
Lung Cancer in the HIV Patient
Trial Information
Screening for Lung Cancer in the HIV Patient
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:
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Stage distribution of HIV-seropositive patients
Outcome Description:
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.
Outcome Time Frame:
Day 1
Safety Issue:
No
Principal Investigator
Malcolm Brock, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
J0491
NCT ID:
NCT01748136
Start Date:
January 2006
Completion Date:
September 2011
Related Keywords:
- Lung Cancer in the HIV Patient
- Lung Neoplasms
Name | Location |
|---|
