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| Name | Class |
|---|---|
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| University of Manchester | OTHER |
| University of Leeds | OTHER |
| Manchester University NHS Foundation Trust |
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Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. The precise mechanism of damage and which areas of the heart are more sensitive to radiation is not currently known. This project uses the analysis of large amounts of existing radiotherapy treatment data to determine this. Establishing detailed radiotherapy dose limits for the heart and the heart's sub-structures will lead to the delivery of heart-sparing radiotherapy, where possible, in lung cancer patients treated in Yorkshire and Greater Manchester. The investigators estimate that this should lead to an improvement in one-year survival of approximately 10%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | Blood samples (FBC, lipids, cholesterol, troponin, CRP, BNP) Cardiac imaging (cardiac CT, cardiac ultrasound, 12-lead ECG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood tests & cardiac imaging | Diagnostic Test | Blood tests (full blood count, lipids, cholesterol, high sensitivity Troponin levels, C-reactive protein (CRP) and brain natriuretic peptide) Cardiac imaging - cardiac CT, cardiac ultrasound, 12-lead ECG |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of radiation dose to the heart assessed using blood test (full blood count) | The effect of radiation dose to the heart assessed using full blood count measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy) | 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels) | The effect of radiation dose to the heart assessed using lipid & cholesterol (LDL & HDL) measurements at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy) | 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using blood test (troponin) | The effect of radiation dose to the heart assessed using troponin measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy) | 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using blood test (C-reactive protein) | The effect of radiation dose to the heart assessed using C-reactive protein measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy) | 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide) | The effect of radiation dose to the heart assessed using brain natriuretic peptide measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corinne Faivre-Finn, PhD | Contact | 0044 (0)161 446 8200 | 8200 | corinne.finn@christie.nhs.uk |
| Elizabeth Craven, MSc | Contact | 0161 446 3045 | elizabeth.craven@manchester.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Corinne Faivre-Finn, PhD | The Christie NHS Foundation Trust / Univerrsity of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Not yet recruiting | Leeds | LS9 7TF | United Kingdom |
No plans to share data
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| OTHER_GOV |
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| 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound) | The effect of radiation dose to the heart assessed using cardiac ultrasound scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac ultrasound measured during the study: parasternal long axis, parasternal short axis, apical 2/4/5 chambers, apical long axis, subcostal and parasternal notch. | 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT) | The effect of radiation dose to the heart assessed using cardiac CT scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac CT scan measured during the study: coronary calcium score (Agaston/Volume) - CAC-RDS 0, CAC-RDS 1, CAC-RDS 2, CAC-RDS 3, CAC-RADS classification. | 4 months (duration of each participant on study) |
| The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG) | The effect of radiation dose to the heart assessed using 12-lead ECG at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the ECG measured during the study: heart rate, rhythm, P wave, QRS complex, QT interval, ST segment & PR interval. | 4 months (duration of each participant on study) |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |