Low Dose Chest Computed Tomography (CT) Screening

NCT01180010 | Completed

• 1 other identifier: UHN REB 08-0294-CE
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's Lymphoma; Lung Cancer; Lung Nodule; CT scan

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

Low Dose CT PROCEDURE

A chest CT uses special radiographic equipment using x-rays to capture images of the chest, and with the aid of a computer, processes the images to create cross-sectional pictures or "slices" of the areas of interest. The images can then be printed out or examined on a monitor. The CT scanner is a large unit with a hole running directly through its center, giving the appearance of a doughnut. During the scanning, patients will lie flat on their back on a table, and they are periodically asked to hold their breath. The table will first move through the scanner to determine the correct starting position. The rest of the scans are made as the table moves more slowly through the cavity in the scanner.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for Hodgkin's Lymphoma

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Hodgkin Disease; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Hodgson, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

CA (1)