Low Dose Chest Computed Tomography (CT) Screening

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01180010

Collaborator

Princess Margaret Hospital, Canada (Other)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner. Depending on the findings of the initial CT scan, we will then either repeat the scan in 1 year, or if indicated, send you for further scans or a biopsy. The information collected in this study will help researchers and clinicians in providing more concrete recommendations and screening guidelines for future survivors of Hodgkin's disease who have had similar exposures to radiation and/or chemotherapy and smoking.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Lymphoma	Procedure: Low Dose CT

Study Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Outcome Measures

Primary Outcome Measures

Lung cancer detection rate using chest CT screening in patients at increased risk of lung cancer after Hodgkin's disease therapy. [5 years]
False-positive rates of using chest CT for lung cancer screening in this population. [5 years]

Secondary Outcome Measures

The stage distribution, clinical characteristics and pathologic features of the detected lung cancer [5 years]
The treatment and treatment outcome of lung cancer after Hodgkin's disease in a cohort of patients undergoing routine chest CT screening [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

Patients with a history of lung cancer
Patients currently receiving treatment for another cancer diagnosis (patients with another cancer, but currently disease-free and not receiving treatment are eligible)
Patients with known diagnosis of any metastatic cancer
Pregnant women. Female patients must: be at least one year post-menopausal, have had a hysterectomy, or have a serum pregnancy test to confirm that they are not pregnant. These measures must be taken in order to avoid doing a CT scan of a pregnant woman.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network, Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Princess Margaret Hospital, Canada

Investigators

Principal Investigator: David Hodgson, MD, University Health Network, Princess Margaret Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01180010

Other Study ID Numbers:

UHN REB 08-0294-CE

First Posted:

Aug 11, 2010

Last Update Posted:

Dec 29, 2016

Last Verified:

Dec 1, 2016

Keywords provided by University Health Network, Toronto

Additional relevant MeSH terms:

Hodgkin Disease

Study Results

No Results Posted as of Dec 29, 2016