Clinical trial NCT01180010: Low Dose Chest Computed Tomography (CT) Screening
Official title: Low-Dose Chest CT for Lung Cancer Screening in Survivors of Hodgkin's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
Lung Cancer
Lung Nodule
CT scan
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2010-08-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for Hodgkin's Lymphoma

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.


Eligibility criteria: Inclusion Criteria:

1. 5 years or longer from initial Hodgkin's disease diagnosis
2. Current age 18 or older
3. Received mediastinal irradiation and/or alkylating-agent based chemotherapy
4. Smoking history of 10-pack years or more, or current smoker

Exclusion Criteria:

1. Patients with a history of lung cancer
2. Patients currently receiving treatment for another cancer diagnosis (patients with another cancer, but currently disease-free and not receiving treatment are eligible)
3. Patients with known diagnosis of any metastatic cancer
4. 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.

Primary outcomes:
measure: Lung cancer detection rate using chest CT screening in patients at increased risk of lung cancer after Hodgkin's disease therapy.
timeFrame: 5 years
measure: False-positive rates of using chest CT for lung cancer screening in this population.
timeFrame: 5 years
Secondary outcomes:
measure: The stage distribution, clinical characteristics and pathologic features of the detected lung cancer
timeFrame: 5 years
measure: The treatment and treatment outcome of lung cancer after Hodgkin's disease in a cohort of patients undergoing routine chest CT screening
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: David Hodgson, MD
role: PRINCIPAL_INVESTIGATOR
References: