Screening for Lung Cancer in the HIV Patient (NA_00036809)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01748136
First received: December 10, 2012
Last updated: May 3, 2013
Last verified: May 2013

December 10, 2012
May 3, 2013
January 2006
September 2011   (final data collection date for primary outcome measure)
Stage distribution of HIV-seropositive patients [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01748136 on ClinicalTrials.gov Archive Site
To create a specimen bank of serum, sputum, and tissue [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
Same as current
Epigenetic analysis of sera and sputa [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.
Same as current
 
Screening for Lung Cancer in the HIV Patient
Screening for Lung Cancer in the HIV Patient

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.

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:

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Lung Cancer in the HIV Patient
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.
Single Arm
CT Scan Arm
Intervention: Device: CT Scan with Spirometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2011
September 2011   (final data collection date for primary outcome measure)
  • 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.
Both
26 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01748136
J0491, NA_00036809
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Malcolm Brock, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP