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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
History of Changes
  Purpose

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.


Condition Intervention
Lung Cancer in the HIV Patient
 Device: CT Scan with Spirometry

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Screening for Lung Cancer in the HIV Patient

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 200
Study Start Date: January 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
CT Scan Arm
 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.

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

Ages Eligible for Study:   26 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748136

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Malcolm Brock, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01748136     History of Changes
Other Study ID Numbers: J0491, NA_00036809
Study First Received: December 10, 2012
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013