Screening for Lung Cancer in the HIV Patient (NA_00036809)
|ClinicalTrials.gov Identifier: NCT01748136|
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : October 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer in the HIV Patient||Device: CT Scan with Spirometry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748136
|Principal Investigator:||Malcolm Brock, MD||Johns Hopkins University|