Screening for Lung Cancer in the HIV Pa… | Clinical Trial

Key information

Conditions

Lung Cancer in the HIV Patient Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Neoplasms Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Thoracic Neoplasms Urogenital Diseases Virus Diseases

Age range

26 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT Scan with Spirometry

Device

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 outcomes

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 outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Acronym: NA_00036809

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Dec 12, 2012
Registry last updated: Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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