Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease

This study is currently recruiting participants.

Verified by Dana-Farber Cancer Institute, October 2009

First Received: January 15, 2008 Last Updated: October 30, 2009 History of Changes

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00601146

Purpose

This research study is being done because patients with a history of chest radiation treatment for Hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. The risk appears to be further increased among patients with a smoking history. Currently, the practice is to recommend annual low-dose chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation treatment and who have at least a moderate smoking history. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner.

Condition	Intervention
Lung Cancer	Procedure: chest computed tomography scan

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Hodgkin Disease Lung Cancer Nuclear Scans

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To prospectively collect data on chest CT screening for patients at increase lung-cancer risk after Hodgkin's disease. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	November 2006
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Once a year for three years

Detailed Description:

- Participants will undergo a chest computed tomography (CT) scan once a year for a 3-year period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Survivors of Hodgkin's disease seen for follow-up at the Brigham and Women's Hosptial Department of Radiation Oncology, the Lance Armstrong Adult Survivorship Clinic and the David B. Perini Jr. Childhood Cancer Survivor Clinic at the Dana Farber-Cancer Institute

Criteria

Inclusion Criteria:

5 years or longer from initial Hodgkin's disease diagnosis
Current age 18 or older
Received mediastinal irradiation and/or alkylating-agent based chemotherapy
Smoking history of 10-pack years or more, or current smoker
Pre-approval from the participant's insurance company for the CT study

Exclusion Criteria:

Patients with a history of lung cancer
Currently receiving treatment for another cancer diagnosis
Known diagnosis of any metastatic cancer
Pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601146

Contacts

Contact: Andrea K. Ng,, MD

617-732-7361

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Andrea K. Ng, MD

Dana-Farber Cancer Institute/Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute/Brigham and Women's Hospital ( Andrea K. Ng, MD )
Study ID Numbers:	06-122
Study First Received:	January 15, 2008
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00601146 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Hodgkin's disease
CT scan

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

ClinicalTrials.gov processed this record on March 18, 2010