Screening for Lung Cancer in the HIV Patient (NA_00036809)
Sidney Kimmel Comprehensive Cancer Center
Information provided by (Responsible Party)
Sidney Kimmel Comprehensive Cancer Center
First received: December 10, 2012
Last updated: October 12, 2016
Last Verified: October 2016
History of Changes
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.
Lung Cancer in the HIV Patient
Device : CT Scan with Spirometry
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Screening for Lung Cancer in the HIV Patient|
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures
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.
|Study Start Date:||January 2006|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
CT Scan Arm
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.
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 to 100 Years|
|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.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748136
Sponsors and CollaboratorsSidney Kimmel Comprehensive Cancer Center
|Principal Investigator:||Malcolm Brock, MD||Johns Hopkins University|
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center|
|ClinicalTrials.gov Identifier:||NCT01748136 History of Changes|
|Other Study ID Numbers:||J0491|
|Study First Received:||December 10, 2012|
|Last Updated:||October 12, 2016|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.