Clinical trial NCT01748136: Screening for Lung Cancer in the HIV Patient
Official title: Screening for Lung Cancer in the HIV Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer in the HIV Patient
HIV Infections
HIV Seropositivity
Lung Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 200
Sex: ALL
Minimum age (years): 26
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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:

Eligibility 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.

Primary outcomes:
measure: Stage distribution of HIV-seropositive patients
timeFrame: Day 1
Secondary outcomes:
measure: To create a specimen bank of serum, sputum, and tissue
timeFrame: 5 years
Other outcomes:
measure: Epigenetic analysis of sera and sputa
timeFrame: 4 weeks
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Malcolm Brock, MD
role: PRINCIPAL_INVESTIGATOR
References: