BHF-COLLATE: UK Prospective, Multi-centre, Observational, Cardio-oncology Anthracycline Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSouth Tees Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Expected lifespan of under one year;
Not expected to complete the planned course of chemotherapy.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Anthracycline patients
Trial outcomes
Primary outcomes
1
Number of participants recruited
Recruitment of 200 participants with ≥75% of patients at medium or higher HFA-ICOS score
Time frame
16 monthsSecondary outcomes
1
Cardiac function
Cardiac function assessed by core lab artificial intelligence (AI) enabled echocardiogram via measurement of left ventricular ejection fraction (LVEF) in (%).
Time frame
12 months2
Cardiac function
Cardiac function assessed by core lab artificial intelligence (AI) enabled echocardiogram via measurement of global longitudinal strain (GLS) in a negative percentage (%).
Time frame
12 months3
Cancer outcomes
Cancer outcomes - Entries recorded in the patient's medical records including cancer relapse/recurrence and diagnosis.
Time frame
12 months4
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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