Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chest computed tomography scan
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Hodgkin's disease, CT scan
Eligibility 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
Sites / Locations
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-dose Chest CT screening
Arm Description
Annual low-dose Chest CT screening
Outcomes
Primary Outcome Measures
To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00601146
First Posted
January 15, 2008
Last Updated
January 9, 2020
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00601146
Brief Title
Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
Official Title
Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2006 (undefined)
Primary Completion Date
December 1, 2010 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
- Participants will undergo a chest computed tomography (CT) scan once a year for a 3-year period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Hodgkin's disease, CT scan
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm study of low-dose Chest CT screening for long-term Hodgkin lymphoma survivors
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose Chest CT screening
Arm Type
Experimental
Arm Description
Annual low-dose Chest CT screening
Intervention Type
Procedure
Intervention Name(s)
chest computed tomography scan
Other Intervention Name(s)
CT scan
Intervention Description
Once a year for three years
Primary Outcome Measure Information:
Title
To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.
Description
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
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea K. Ng, MD
Organizational Affiliation
Dana-Farber Cancer Institute/Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
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