Clinical trial · Observational

Screening for Lung Cancer in the HIV Patient

NCT01748136CI-TRIAL-00037852NA_00036809completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
HIV Infections	—	UNRESOLVED	—
HIV Seropositivity	—	UNRESOLVED	—
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Lung Cancer in the HIV Patient	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
CT Scan with Spirometry	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Single Arm
description
CT Scan Arm
interventionNames
1. Device: CT Scan with Spirometry

Primary outcomes (1)

measure
Stage distribution of HIV-seropositive patients
timeFrame
Day 1
description
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 (1)

measure
To create a specimen bank of serum, sputum, and tissue
timeFrame
5 years
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 26 Years
Maximum age: 100 Years

Show eligibility criteria text

* 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.

References

Publications (0)

Data not yet available

No reference posted for this study.