Screening for Lung Cancer in the HIV Patient

HIV Infections Clinical Trial

— NA_00036809  

Official title:

Screening for Lung Cancer in the HIV Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748136
• Other study ID #: J0491
• Secondary ID: NA_00036809
• Status: Completed
• Start date: January 2006
• Est. completion date: September 2011

Study information

• Verified date: March 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity
• Lung Cancer
• Lung Cancer in the HIV Patient
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epigenetic analysis of sera and sputa	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.	4 weeks
Primary	Stage distribution of HIV-seropositive patients	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.	Day 1
Secondary	To create a specimen bank of serum, sputum, and tissue	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.	5 years