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NCT Number: NCT01180010

Low Dose Chest Computed Tomography (CT) Screening

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.

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Key information

Conditions

Hodgkin's Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2010
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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