Lung CancerNCT00601146
Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
A study testing chest computed tomography scan in people with Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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
- Lung Cancer
- What is being tested?
- chest computed tomography scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2006to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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
- Pre-approval from the participant's insurance company for the CT study
Who cannot join
- Patients with a history of lung cancer
- Currently receiving treatment for another cancer diagnosis
- Known diagnosis of any metastatic cancer
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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. Currently, the practice is to recommend annual low-dose chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation treatment and who have at least a moderate 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.
Read the detailed description
- Participants will undergo a chest computed tomography (CT) scan once a year for a 3-year period.
- Conditions
- Lung Cancer
- Being tested
- chest computed tomography scan
- Keywords
- Hodgkin's disease, CT scan
- Medical subject headings
- Lung Neoplasms, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest computed tomography scanProcedure or surgery
Also called CT scan
Once a year for three years
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Chest CT screening | Experimental | Annual low-dose Chest CT screening Receives: Procedure: chest computed tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.
In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study start1 Nov 2006
- Primary completion1 Dec 2010
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study of low-dose Chest CT screening for long-term Hodgkin lymphoma survivors
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Andrea K. Ng, MD, Dana-Farber Cancer Institute
- Investigators
- Andrea K. Ng, MD, Principal investigator, Dana-Farber Cancer Institute/Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601146
- Sponsor's protocol ID
- 06-122
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2008
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00601146
- Acronym / sponsor ID
- 06-122
- Conditions
- Lung Cancer
- Keywords
- Hodgkin's disease, CT scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 1 Nov 2006
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Posted 17 Feb 2016
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. Currently, the practice is to recommend annual low-dose chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation treatment and who have at least a moderate 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.
Detailed description
- Participants will undergo a chest computed tomography (CT) scan once a year for a 3-year period.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study of low-dose Chest CT screening for long-term Hodgkin lymphoma survivors
| Arm | Type | Receives |
|---|---|---|
| Low-dose Chest CT screening | Experimental | Procedure: chest computed tomography scanAnnual low-dose Chest CT screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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
- Pre-approval from the participant's insurance company for the CT study
Key exclusion criteria (4 listed)
- Patients with a history of lung cancer
- Currently receiving treatment for another cancer diagnosis
- Known diagnosis of any metastatic cancer
- Pregnant women
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 |
|---|---|---|
| chest computed tomography scanAlso: CT scanOnce a year for three years | Procedure or surgery | Low-dose Chest CT screening |
Primary outcome
To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.
Time frame: 3 years
In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrea K. Ng, MD principal investigator
Dana-Farber Cancer Institute/Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest computed tomography scan in people with Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 5 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease. (time frame: 3 years). 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 21 Jan 2020.