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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00601146
Other study ID # 06-122
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2006
Est. completion date December 1, 2019

Study information

Verified date January 2020
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 1, 2019
Est. primary completion date December 1, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
chest computed tomography scan
Once a year for three years

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 years
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