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Low Dose Chest Computed Tomography (CT) Screening

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ClinicalTrials.gov Identifier: NCT01180010
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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
Hodgkin's Lymphoma Procedure: Low Dose CT

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 : August 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Low Dose CT
    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.


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

Secondary Outcome Measures :
  1. The stage distribution, clinical characteristics and pathologic features of the detected lung cancer [ Time Frame: 5 years ]
  2. The treatment and treatment outcome of lung cancer after Hodgkin's disease in a cohort of patients undergoing routine chest CT screening [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for Hodgkin's Lymphoma
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180010


Locations
Canada, Ontario
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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01180010     History of Changes
Other Study ID Numbers: UHN REB 08-0294-CE
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by University Health Network, Toronto:
Hodgkin's Lymphoma
Lung Cancer
Lung Nodule
CT scan

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases