Screening for Lung Cancer in the HIV Patient (NA_00036809)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748136
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : October 13, 2016
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Lung Cancer in the HIV Patient Device: CT Scan with Spirometry Not Applicable

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:

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Screening for Lung Cancer in the HIV Patient
Study Start Date : January 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Stage distribution of HIV-seropositive patients [ Time Frame: Day 1 ]
    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 :
  1. To create a specimen bank of serum, sputum, and tissue [ Time Frame: 5 years ]
    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:
  1. Epigenetic analysis of sera and sputa [ Time Frame: 4 weeks ]
    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.

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Ages Eligible for Study:   26 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748136

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

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT01748136     History of Changes
Other Study ID Numbers: J0491
NA_00036809 ( Other Identifier: JHMIRB )
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

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