Condition category
Cancer
Date applied
29/08/2018
Date assigned
31/08/2018
Last edited
07/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Lymphoma is a type of cancer affecting the infection-fighting cells of the immune system called the lymphocytes (or white cells). There are different types of lymphoma depending on the type of cells affected. The two most common types include non-Hodgkin's and Hodgkin's lymphoma.
In the UK, lymphoma is the fifth most common type of cancer. There are many different treatment options available for lymphoma; the most common treatment is chemotherapy. Chemotherapy uses anticancer (cytotoxic) drugs to destroy cancer cells by disrupting their growth. The most frequent cytotoxic drugs used are anthracyclines. These drugs have proven to be beneficial in the treatment of lymphoma and other types of cancer. However, despite their excellent anti-cancer properties, heart damage is considered to be one of the associated side effects of these agents. Once this occurs, heart damage can affect the length and quality of life of those patients affected. Therefore early detection of heart side effects is crucial.
Currently in the UK, detecting anthracycline-related heart damage relies on heart scans called echocardiography (or echo). However current echo measurements used to detect these changes are limited. These measurements can only find changes when significant damage has already occurred.
Therefore this study has been designed to explore better means of detecting early anthracycline-related heart damage using novel echo measurements. Furthermore we would like to evaluate which patient specific factors increase the risk of developing anthracycline-related heart damage.

Who can participate?
Patients with a new diagnosis of lymphoma who have received anthracycline-based chemotherapy between January 2015 to January 2018

What does the study involve?
Due to retrospective nature of the study no additional study procedures will be carried out. Patients will not be required to attend any additional hospital visits for the purpose of this study. Echocardiograms done as part of standard care (before chemotherapy, mid treatment and post chemotherapy) will be analysed using advanced echo measurements to explore whether better methods of detecting early anthracycline induced cardiotoxicity exist. Furthermore patients’ medical records will be reviewed to assess which factors increase the risk of developing anthracycline related heart damage.

What are the possible benefits and risks of participating?
The study is observational, exploratory and retrospective. No additional intervention or hospital visits are required for the purpose of this study and results obtained and published will not identify any individual participant. The novel echo measurements in question are not yet in routine clinical use. Thus, any findings are exploratory and as such will not impact patient management. This study will allow the exploration of novel echocardiographic measurements in detecting early anthracycline-related heart damage.

Where is the study run from?
James Cook University Hospital, Middlesbrough (UK)

When is the study starting and how long is it expected to run for?
July 2018 to July 2019

Who is funding the study?
South Tees Research and Development Research Fund (UK)

Who is the main contact?
Dr Sharareh Vahabi
sharareh.vahabi@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sharareh Vahabi

ORCID ID

http://orcid.org/0000-0002-6683-6105

Contact details

South Tees NHS Foundation Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
Middlesbrough
TS4 3BW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Detection of early anthracycline induced cardiotoxicity using speckle tracking echocardiography in patients with lymphoma: a retrospective cohort study

Acronym

Study hypothesis

To check whether advanced strain measurements using speckle tracking echocardiography is able to detect subclinical cardiac dysfunction in patients with lymphoma treated with anthracyclines

Ethics approval

Approved 29/10/2018, South East Scotland Research Ethics Committee 02 (Waverley Gate, 2 - 4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5674; Joyce.Clearie@nhslothian.scot.nhs.uk), REC ref: 18/SS/0139

Study design

Observational single-centre retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Lymphoma

Intervention

This will be a single-centre, retrospective cohort study at the James Cook University Hospital in Middlesbrough. Patients diagnosed with lymphoma between January 2015 to January 2018 will be identified via the caring haematology team through a computerised search of the haematology database. As part of standard care, patients will have had an echocardiogram pre-chemotherapy, mid-treatment and post chemotherapy. The echocardiograms will be further analysed using advanced speckle tracking echocardiography in an offline workstation at The James Cook University Hospital echo core laboratory. This will allow us to explore whether any single or combined advanced echo measurements can detect early anthracycline induced cardiotoxicity in those patients who have developed a reduction in their heart function using conventional methods, to see whether this is evident at an earlier time point and whether the measures are reliable and reproducible. Furthermore patients' medical notes will be reviewed to obtain medical history and medication and to be able to link the information obtained with the echo measurements to assess which patient specific characteristics further increase the risk of anthracycline induced cardiotoxicity.

Intervention type

Other

Phase

Drug names

Primary outcome measure

In addition to describing the medical characteristics of patients with lymphoma in the study, the cardiac function of patients will be measured. This will be assessed by echocardiogram, including:
1. Measurement of left ventricular ejection fraction (LVEF)
2. Measurement of all novel echocardiographic strain parameters on already performed echo scans done prior to chemotherapy, mid-treatment and post chemotherapy:
2.1. Left ventricular global longitudinal strain (GLS)
2.2. Left ventricular global radial strain (GRS)
2.3. Left ventricular global circumferential strain (GCS)
2.4. Torsion and twist
2.5. Right ventricular free wall strain
2.6. Left and right atrial strain
2.7. Strain rates

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/07/2018

Overall trial end date

01/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. New diagnosis of histopathologically-confirmed lymphoma between January 2015 and January 2018
2. Received anthracycline based chemotherapy for the treatment of their lymphoma

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Total final enrolment

45

Participant exclusion criteria

1. No adequate echocardiographic imaging on PACS database
2. Explicit dissent and unwillingness to participate in research detailed in the medical notes

Recruitment start date

01/01/2015

Recruitment end date

31/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The James Cook University Hospital
South Tees NHS Foundation Trust Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

South Tees NHS Foundation Trust

Sponsor details

South Tees NHS Foundation Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
Middlesbrough
TS4 3BW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Retrospective study so no need for funding for this study

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
There are no plans to disseminate any results that include identifiable personal data. Data will be fully anonymised prior to publication. Results will be presented in aggregated form in publications. In order to minimise exposure to patients' identifiable information we feel it is unnecessary to obtain patient phone number and address to disseminate the results. Specific consent is not being sought, and findings will not affect their clinical care.

Intention to publish date

31/12/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2020 results abstract in https://doi.org/10.1093/ehjci/jez319.816 (added 06/07/2020)

Publication citations

Additional files

Editorial Notes

07/07/2020: Ethics approval details and total final enrolment number added. 06/07/2020: Publication reference added, intention to publish date changed from 01/09/2018 to 31/12/2020.