Cancer and / or Hematological MalignancyBHF-COLLATENCT07864467
BHF-COLLATE: UK Prospective, Multi-centre, Observational, Cardio-oncology Anthracycline Registry
An observational study of Cancer and / or Hematological Malignancy and Anthracycline-induced Cardiotoxicity, run by South Tees Hospitals NHS Foundation Trust at 6 sites in United Kingdom.
Trial summary
The study aims to collect information on how cancer treatment affects heart health. This will include collecting baseline medical information, storing blood samples, recording cancer treatment, and analysing heart scans across about 200 patients in several UK hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer and / or Hematological Malignancy, Anthracycline-induced Cardiotoxicity
- How many people
- 200 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 30 Sep 2026to 30 Nov 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants will be recruited from centres treating haemato-oncology and oncology patients and will be adult patients (18 years and above) who are due to receive anthracycline-based chemotherapy for their cancer* and provide written informed consent prior to study participation. *Participants are likely to be those being treated for breast cancer, lymphoma and sarcoma. Where patients need an expedited start to their anthracycline-based chemotherapy regimen for urgent clinical reasons that precludes enrolment prior to the start of cycle 1 (e.g. patients with NHL where treatment must start within a couple of days), they can still be included as long as consent, baseline assessments and eligibility is confirmed prior to the start of cycle 2.
Who may be able to join
- Adult patients with confirmed solid organ or haematological malignancy;
- Adults aged 18 years or older;
- Planned to receive anthracycline chemotherapy; or prior to the start of the second cycle of anthracycline chemotherapy for those who required an urgent start to their chemotherapy for clinical reasons;
- Provision of written informed consent.
Who cannot join
- Expected lifespan of under one year;
- Not expected to complete the planned course of chemotherapy.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites
County Durham and Darlington NHS Foundation Trust
Darlington, DL3 6HX
Sophie Haney, 01913332333, sophiehaney@nhs.net
Greater Glasgow and Clyde NHS Trust
Glasgow, G12 0XH
Matthew Wilson, 01412014444, matthew.wilson@nhs.scot
Hull University Teaching Hospitals NHS Foundation Trust
Hull, HU3 2JZ
James Bailey, 01482875875, james.bailey6@nhs.net
Barts Health NHS Trust
London, E1 2ES
Charlotte Manisty, 02073777000, charlotte.manisty@nhs.net
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS43BW
David Austin, 01642850850, david.austin@nhs.net
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE77DN
Christopher Plummer, 01912336161, chris.plummer@nhs.net
About this study
The study aims to collect information on how cancer treatment affects heart health. This will include collecting baseline medical information, storing blood samples, recording cancer treatment, and analysing heart scans across about 200 patients in several UK hospitals. We are aiming to: collect health information and store blood samples, alongside heart scans, to learn more about heart health after chemotherapy; improve understanding of why some patients develop heart problems, so that better tests, monitoring, and treatments can be developed in the future; build a UK-wide research group.
Read the detailed description
The overarching rationale of BHF-COLLATE is to establish the first phase of a UK multicentre cardio-oncology registry platform focused on anthracycline chemotherapy. Phase I is primarily designed as a feasibility and infrastructure building registry to establish a functioning multidisciplinary research network, harmonised study procedures, core imaging and biobanking workflows, and scalable data collection processes capable of supporting future national registry expansion and interventional clinical trials.
In parallel, exploratory clinical, imaging and biomarker analyses will improve understanding of the cardiovascular consequences of anthracycline chemotherapy in real-world clinical practice and help inform the design of future translational and interventional cardio-oncology studies.
Through the establishment of this first phase, and recruitment of a multicentre UK anthracycline registry, the study aims to comprehensively phenotype patients receiving anthracycline chemotherapy in order to:
establish a collaborative research network and platform to support future interventional clinical trials in cardio-oncology facilitate translational research through the biobanking of clinical samples linked to detailed baseline clinical assessments, cardiac imaging, and longitudinal follow-up data generate mechanistic insights to inform the design of future clinical trials and the development of improved diagnostic, risk-stratification, and surveillance strategies.
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anthracycline patients | Adult patients with confirmed solid organ or haematological malignancy; Adults aged 18 years or older; Planned to receive anthracycline chemotherapy; or prior to the start of the second cycle of anthracycline chemotherapy for those who required an urgent start to their chemotherapy for clinical reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Recruitment of 200 participants with ≥75% of patients at medium or higher HFA-ICOS score
Measured: 16 months
Secondary outcomes (8)
Cardiac function
Cardiac function assessed by core lab artificial intelligence (AI) enabled echocardiogram via measurement of left ventricular ejection fraction (LVEF) in (%).
Measured: 12 months
Cardiac function
Cardiac function assessed by core lab artificial intelligence (AI) enabled echocardiogram via measurement of global longitudinal strain (GLS) in a negative percentage (%).
Measured: 12 months
Cancer outcomes
Cancer outcomes - Entries recorded in the patient's medical records including cancer relapse/recurrence and diagnosis.
Measured: 12 months
Cancer outcomes
Cancer treatment completeness including number of cycles whether dosage was changed/delayed/reduced/discontinued - total dose of anthracycline received in (mg/m²) of body surface area.
Measured: 12 months
Cardiovascular Outcomes
1Cardiovascular outcomes including cancer therapy related cardiac dysfunction (CTRCD). Entries as recorded in the patients' medical records including:
- new diagnoses of heart failure
- new diagnoses of atrial fibrillation
- new diagnoses of myocardial infarction
- new diagnoses of stroke or Transient Ischaemic Attack (TIA)
- new diagnoses of deep vein thrombosis (DVT)
- new diagnoses of Pulmonary Embolous (PE).
Measured: 12 months
Quality of Life
Measurement of health-related quality of life of cancer patients through completion of EORTC-QLQ-C30 questionnaire.
Most items use a 4-point scale ranging from 1 ("Not at all") to 4 ("Very much"); the global health/QoL items towards the end of the questionnaire use a 7-point scale from 1 ("Very poor") to 7 ("Excellent").
Overall scores are calculated by adding up the numerical response values in a section and calculating an average score. This score is then converted to a 0-100 score using the scoring manual.
A higher score means a better level of functioning or higher quality of life, a lower score signifies lower QoL.
Measured: 12 months
Quality of Life
Measurement of patient-reported Quality of Life assessments through completion of the EQ-5D-5L questionnaire.
Measured: 12 months
Biobanking and data collection
To facilitate translational research through the biobanking of clinical samples (including biomarkers and genomics)
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 posted7 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer and / or Hematological MalignancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- South Tees Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Austin, Principal investigator, South Tees Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864467
- Sponsor's protocol ID
- 26/003
- Other IDs
- FS/CRA/25/23080
- Acronym
- BHF-COLLATE
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to sharing samples and de-identified individual level data, where a rigorous research question may be answered. Appropriate data and material sharing agreements and Data Protection Impact Assesments (DPIA)s will be put in place where required. The research team including the Chief Investigator and Sponsor will consider proposals from researchers as long as there is no constraint due to: Ethical approval and informed consent The request does not require the data/samples prior to publication of key findings or appropriate agreements are able to be place to protect the original work. The request for data and/or samples does not extend beyond that which is needed to answer the specific research question. Overall responsibility for data collection lies with the Chief Investigator. Study data will be handled, computerised and stored in accordance with the Data Protection Act 2018, and local policy.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BHF-COLLATE: UK Prospective, Multi-centre, Observational, Cardio-oncology Anthracycline Registry
- ClinicalTrials.gov ID
- NCT07864467
- Acronym / sponsor ID
- BHF-COLLATE / 26/003
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- South Tees Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 7 Oct 2026 (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.
The study aims to collect information on how cancer treatment affects heart health. This will include collecting baseline medical information, storing blood samples, recording cancer treatment, and analysing heart scans across about 200 patients in several UK hospitals. We are aiming to: collect health information and store blood samples, alongside heart scans, to learn more about heart health after chemotherapy; improve understanding of why some patients develop heart problems, so that better tests, monitoring, and treatments can be developed in the future; build a UK-wide research group.
Detailed description
The overarching rationale of BHF-COLLATE is to establish the first phase of a UK multicentre cardio-oncology registry platform focused on anthracycline chemotherapy. Phase I is primarily designed as a feasibility and infrastructure building registry to establish a functioning multidisciplinary research network, harmonised study procedures, core imaging and biobanking workflows, and scalable data collection processes capable of supporting future national registry expansion and interventional clinical trials.
In parallel, exploratory clinical, imaging and biomarker analyses will improve understanding of the cardiovascular consequences of anthracycline chemotherapy in real-world clinical practice and help inform the design of future translational and interventional cardio-oncology studies.
Through the establishment of this first phase, and recruitment of a multicentre UK anthracycline registry, the study aims to comprehensively phenotype patients receiving anthracycline chemotherapy in order to:
establish a collaborative research network and platform to support future interventional clinical trials in cardio-oncology facilitate translational research through the biobanking of clinical samples linked to detailed baseline clinical assessments, cardiac imaging, and longitudinal follow-up data generate mechanistic insights to inform the design of future clinical trials and the development of improved diagnostic, risk-stratification, and surveillance strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anthracycline patients | – | –Adult patients with confirmed solid organ or haematological malignancy; Adults aged 18 years or older; Planned to receive anthracycline chemotherapy; or prior to the start of the second cycle of anthracycline chemotherapy for those who required an urgent start to their chemotherapy for clinical reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from centres treating haemato-oncology and oncology patients and will be adult patients (18 years and above) who are due to receive anthracycline-based chemotherapy for their cancer* and provide written informed consent prior to study participation. *Participants are likely to be those being treated for breast cancer, lymphoma and sarcoma. Where patients need an expedited start to their anthracycline-based chemotherapy regimen for urgent clinical reasons that precludes enrolment prior to the start of cycle 1 (e.g. patients with NHL where treatment must start within a couple of days), they can still be included as long as consent, baseline assessments and eligibility is confirmed prior to the start of cycle 2.
Key inclusion criteria (4 listed)
- Adult patients with confirmed solid organ or haematological malignancy;
- Adults aged 18 years or older;
- Planned to receive anthracycline chemotherapy; or prior to the start of the second cycle of anthracycline chemotherapy for those who required an urgent start to their chemotherapy for clinical reasons;
- Provision of written informed consent.
Key exclusion criteria (2 listed)
- Expected lifespan of under one year;
- Not expected to complete the planned course of chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants recruited
Time frame: 16 months
Recruitment of 200 participants with ≥75% of patients at medium or higher HFA-ICOS score
8 secondary outcomes
Cardiac function
Time frame: 12 months
Cardiac function
Time frame: 12 months
Cancer outcomes
Time frame: 12 months
Cancer outcomes
Time frame: 12 months
Cardiovascular Outcomes
Time frame: 12 months
Quality of Life
Time frame: 12 months
Quality of Life
Time frame: 12 months
Biobanking and data collection
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. We are committed to sharing samples and de-identified individual level data, where a rigorous research question may be answered. Appropriate data and material sharing agreements and Data Protection Impact Assesments (DPIA)s will be put in place where required. The research team including the Chief Investigator and Sponsor will consider proposals from researchers as long as there is no constraint due to: Ethical approval and informed consent The request does not require the data/samples prior to publication of key findings or appropriate agreements are able to be place to protect the original work. The request for data and/or samples does not extend beyond that which is needed to answer the specific research question. Overall responsibility for data collection lies with the Chief Investigator. Study data will be handled, computerised and stored in accordance with the Data Protection Act 2018, and local policy.
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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.
David Austin principal investigator
South Tees Hospitals NHS Foundation Trust
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and / or Hematological Malignancy and Anthracycline-induced Cardiotoxicity, run by South Tees Hospitals NHS Foundation Trust at 6 sites 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 2 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BHF COLLATE study team (01642 850 850 ext. 58441, stees.bhfcollate@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: 16 months). 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 7 Oct 2026.