Hodgkin's LymphomaNCT01180010
Low Dose Chest Computed Tomography (CT) Screening
An observational study of Hodgkin's Lymphoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Low Dose CT
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for Hodgkin's Lymphoma
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Low-Dose Chest CT for Lung Cancer Screening in Survivors of Hodgkin's Disease
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
- Being tested
- Low Dose CT
- Keywords
- Hodgkin's Lymphoma, Lung Cancer, Lung Nodule, CT scan
- Medical subject headings
- Hodgkin Disease, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose CTProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer detection rate using chest CT screening in patients at increased risk of lung cancer after Hodgkin's disease therapy.
Measured: 5 years
False-positive rates of using chest CT for lung cancer screening in this population.
Measured: 5 years
Secondary outcomes (2)
The stage distribution, clinical characteristics and pathologic features of the detected lung cancer
Measured: 5 years
The treatment and treatment outcome of lung cancer after Hodgkin's disease in a cohort of patients undergoing routine chest CT screening
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- David Hodgson, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180010
- Sponsor's protocol ID
- UHN REB 08-0294-CE
- Status last verified
- Dec 2016
- First submitted
- 10 Aug 2010
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Chest CT for Lung Cancer Screening in Survivors of Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT01180010
- Acronym / sponsor ID
- UHN REB 08-0294-CE
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, Lung Cancer, Lung Nodule, CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Aug 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for Hodgkin's Lymphoma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose CTA 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. | Procedure or surgery | – |
Primary outcome
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
False-positive rates of using chest CT for lung cancer screening in this population.
Time frame: 5 years
2 secondary outcomes
The stage distribution, clinical characteristics and pathologic features of the detected lung cancer
Time frame: 5 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hodgson, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's Lymphoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.