Hodgkin LymphomaNCT04986189
Lung Screening in People Cured of Hodgkin Lymphoma
A study testing Low dose CT thorax in people with Hodgkin Lymphoma and Lung Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hodgkin Lymphoma, Lung Cancer
- What is being tested?
- Low dose CT thorax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2021to 31 Aug 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80
- 5 year or more survivor of HL
- Any of: a) treated with radiotherapy for HL with radiation dose to the lung b) an alkylating agent containing chemotherapy regimen known to increase lung cancer risk
- Living within approximately 40 miles of The Christie Hospital
Who cannot join
- Previous diagnoses of malignant neoplasm of trachea, bronchus, lung, thymus or pleura
- A current diagnosis of metastatic cancer
- Residents in nursing homes or housebound
- Had a CT scan of the thorax within the last 12 months
- Pregnant women
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study
A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening
- Conditions
- Hodgkin Lymphoma, Lung Cancer
- Being tested
- Low dose CT thorax
- Keywords
- screening, low dose 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 CT thoraxDiagnostic test
A low dose CT scan of the thorax to screen for lung cancer
| Study group | Role | What they receive |
|---|---|---|
| Invitation to have a low dose CT thorax | Other | All participants are invited to undergo a low dose CT thorax Receives: Diagnostic Test: Low dose CT thorax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study
Feasibility outcome
Measured: Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan
Secondary outcomes (13)
Decisional conflict scores in those who receive the decision aid measured using the validated Decisional Conflict Scale (score 0-100 with higher score representing higher levels of decisional conflict)
Measured: 14 months
Preparedness for decision making in those who receive the decision aid using the validated Preparedness for Decision Making Scale (score 0-100 with higher score representing higher perceived levels of preparedness for decision making)
Measured: 4 months
Lung cancer screening knowledge pre and post receipt of the decision aid measured using a novel scale (score 0-16 with higher score representing high levels of knowledge about lung cancer screening)
Measured: 4 months
The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice
Measured: 6 and 12 months following CT scan
Anxiety levels pre and post screening measured using the State Trait Anxiety Inventory -6 validated scale (score 6-24 with higher score representing higher levels of anxiety)
Measured: 2 months post CT scan
Cancer worry severity levels pre and post screening measured using measured using 4-item Brief Worry Scale (score 4-20 with higher score representing higher cancer worry severity levels)
Measured: 12 months
Cancer worry frequency measured using intrusive thoughts subscale from Revised impact of events scale (score 6-30 with higher score representing more frequent cancer worry)
Measured: 12 months
Health related quality of life pre-screening then 6 and 12 months post screening measured using the validated SF-12 (short-form-12) scale (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)
Measured: 12 months
The rates of smoking cessation 6 and 12 months following screening
Measured: 12 months
The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)
Measured: 2 months
Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines
Measured: 12 months
The type and prevalence of incidental findings on screening scans
Measured: 12 months
The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Aug 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986189
- Sponsor's protocol ID
- CFTSp204
- Status last verified
- Nov 2024
- First submitted
- 26 May 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Broadbent R, Crosbie P, Armitage CJ, Taylor B, Tenant S, Mercer J, Radford J, Linton K. Pilot study of lung cancer screening for survivors of Hodgkin lymphoma. Haematologica. 2024 Oct 1;109(10):3305-3313. doi: 10.3324/haematol.2023.283287.
PubMed 37981893
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04986189
- Acronym / sponsor ID
- CFTSp204
- Conditions
- Hodgkin Lymphoma, Lung Cancer
- Keywords
- screening, low dose CT scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 2 Aug 2021 (actual)
- 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.
A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invitation to have a low dose CT thorax | Other | Diagnostic Test: Low dose CT thoraxAll participants are invited to undergo a low dose CT thorax |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-80
- 5 year or more survivor of HL
- Any of: a) treated with radiotherapy for HL with radiation dose to the lung b) an alkylating agent containing chemotherapy regimen known to increase lung cancer risk
- Living within approximately 40 miles of The Christie Hospital
Key exclusion criteria (6 listed)
- Previous diagnoses of malignant neoplasm of trachea, bronchus, lung, thymus or pleura
- A current diagnosis of metastatic cancer
- Residents in nursing homes or housebound
- Had a CT scan of the thorax within the last 12 months
- 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 |
|---|---|---|
| Low dose CT thoraxA low dose CT scan of the thorax to screen for lung cancer | Diagnostic test | Invitation to have a low dose CT thorax |
Primary outcome
Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study
Time frame: Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan
Feasibility outcome
13 secondary outcomes
Decisional conflict scores in those who receive the decision aid measured using the validated Decisional Conflict Scale (score 0-100 with higher score representing higher levels of decisional conflict)
Time frame: 14 months
Preparedness for decision making in those who receive the decision aid using the validated Preparedness for Decision Making Scale (score 0-100 with higher score representing higher perceived levels of preparedness for decision making)
Time frame: 4 months
Lung cancer screening knowledge pre and post receipt of the decision aid measured using a novel scale (score 0-16 with higher score representing high levels of knowledge about lung cancer screening)
Time frame: 4 months
The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice
Time frame: 6 and 12 months following CT scan
Anxiety levels pre and post screening measured using the State Trait Anxiety Inventory -6 validated scale (score 6-24 with higher score representing higher levels of anxiety)
Time frame: 2 months post CT scan
Cancer worry severity levels pre and post screening measured using measured using 4-item Brief Worry Scale (score 4-20 with higher score representing higher cancer worry severity levels)
Time frame: 12 months
Cancer worry frequency measured using intrusive thoughts subscale from Revised impact of events scale (score 6-30 with higher score representing more frequent cancer worry)
Time frame: 12 months
Health related quality of life pre-screening then 6 and 12 months post screening measured using the validated SF-12 (short-form-12) scale (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)
Time frame: 12 months
The rates of smoking cessation 6 and 12 months following screening
Time frame: 12 months
The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)
Time frame: 2 months
Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines
Time frame: 12 months
The type and prevalence of incidental findings on screening scans
Time frame: 12 months
The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework
Time frame: 12 months
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 4 Nov 2024.
- Derived from this study: PubMed 37981893Broadbent R, Crosbie P, Armitage CJ, Taylor B, Tenant S, Mercer J, Radford J, Linton K. Pilot study of lung cancer screening for survivors of Hodgkin lymphoma. Haematologica. 2024 Oct 1;109(10):3305-3313. doi: 10.3324/haematol.2023.283287.
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose CT thorax in people with Hodgkin Lymphoma and Lung Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
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 6 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 4 Nov 2024. 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 United Kingdom. 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?
Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study (time frame: Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986189, which also lists 1 linked publication.
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 4 Nov 2024.