CT Scans in Screening for Lung Cancer in Current and Former Smokers - Full Text View

Sponsors and Collaborators:	University of Nebraska National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00625690

Purpose

RATIONALE: Screening tests, such as CT scanning, may help doctors find cancer cells early and plan better treatment for lung cancer.

PURPOSE: This clinical trial is studying how well a lung cancer screening program using CT scanning works in current and former smokers.

Condition	Intervention
Lung Cancer	Other: screening questionnaire administration Procedure: computed tomography Procedure: evaluation of cancer risk factors Procedure: study of high risk factors

Study Type:	Interventional
Study Design:	Screening, Open Label
Official Title:	Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans Surgery

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of establishing a lung cancer screening program at the University of Nebraska Medical Center [ Designated as safety issue: No ]
Feasibility of screening 100 high-risk individuals with high-resolution CT scanning for the presence of suspicious pulmonary nodules [ Designated as safety issue: No ]
Comparison of work-up on all study participants with abnormal results within a defined time period from initial screening [ Designated as safety issue: No ]
Establishment of normative parameters for screening efficiency [ Designated as safety issue: No ]
Frequency of suspicious nodules at baseline [ Designated as safety issue: No ]
Frequency of invasive procedures for diagnosis [ Designated as safety issue: No ]
Frequency of surgical evaluation [ Designated as safety issue: No ]
Complication rates with diagnostic work-up [ Designated as safety issue: No ]
Surgical management [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2005
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Eligibility

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS:

Body weight less than 140 kg (308 pounds)
Able to lie flat
Able to comply with long-term follow-up
Functional capacity and willingness to undergo diagnostic work-up of suspicious nodules and curative therapy if lung cancer is detected
Nursing mothers allowed
No cognitive impairment that would preclude providing informed consent
No other concurrent or prior malignancy within the past five years except superficial basal cell carcinoma or nonmelanoma skin cancer
Able to come to clinic for screening
No condition that would preclude screening, diagnosis, or surgical treatment
Not pregnant
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625690

Locations

United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Apar K. Ganti, MD

University of Nebraska

More Information

Additional Information:

No publications provided

Study ID Numbers:	CDR0000582377, UNMC-06405
Study First Received:	February 27, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00625690 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 04, 2009