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

January 9, 2020 updated by: Andrea K. Ng, MD, Dana-Farber Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose Chest CT screening
Annual low-dose Chest CT screening
Procedure: chest computed tomography scan
Once a year for three years
Other Names:
  • CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.
Time Frame: 3 years
In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Andrea K. Ng, MD, Dana-Farber Cancer Institute/Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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