Condition category
Cancer
Date applied
09/05/2019
Date assigned
10/05/2019
Last edited
09/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gareth Veal

ORCID ID

http://orcid.org/0000-0002-1897-8678

Contact details

Northern Institute for Cancer Research
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 208 4332
g.j.veal@newcastle.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NCCPG TDM 2018

Study information

Scientific title

A clinical pharmacology study to investigate the utility of therapeutic drug monitoring in challenging childhood cancer patient populations

Acronym

Study hypothesis

The use of therapeutic drug monitoring relates to the measurement of drug levels in biological samples to individualise patient treatment through changing drug doses. This is conducted with a view to improving how effective the drug is and/or reducing side effects.

Over several years we have identified childhood cancer patients who clearly benefit from this treatment approach with commonly used cancer drugs. These 'hard to treat' patients include pre-term infants and newborn children, patients with no or poorly functioning kidneys, obese children and patients receiving high dose chemotherapy. The current study will allow us to maximise the information that is generated from treating patients in this way, with information relating to individual patient exposure and clinical outcome collected from a significant number of patients.

Ethics approval

Approved 23/01/2019, North East - Newcastle and North Tyneside 2 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Dr, Newcastle upon Tyne NE2 4NQ; 0207 104 8019; nrescommittee.northeast-newcastleandnorthtyneside2@nhs.net), ref: 18/NE/0384

Study design

Multi-centre basic science study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Cancer

Intervention

The trial will recruit an estimated 150 patients within defined 'hard to treat' categories. These include pre-term infants and newborns, patients with impaired kidney function or no kidneys, patients receiving high dose chemotherapy, obese patients, and those receiving chemotherapy where the drug is injected directly into the tumour.
Patients will be referred to the study following decisions made by their treating clinician to use Therapeutic Drug Monitoring as part of the patient's standard treatment.
Clinical and response data will be collected following each cycle of treatment and all relevant clinical information and data generated will be entered into a patient registry in an anonymised form available only to registered medical staff with individual password-protected user accounts. Clinicians will then be able to use this information when treating future patients within these 'hard to treat' groups.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Definition of the pharmacokinetics of widely used anti-cancer drugs in defined 'hard to treat' patient populations; assessment of factors associated with pharmacokinetic variability in defined 'hard to treat' patient populations.
Measured by analysis of samples from patients.
Time point - end of study.

Secondary outcome measures

1. Establishment of a national registry to provide access to data relating to the dosing of a comprehensive library of chemotherapeutic in defined 'hard to treat' patient populations.
Measured by analysis of samples from patients - data published on trial website.
Time point - ongoing throughout study as data become available.

2. Development of national treatment guidelines supporting the use of Therapeutic Drug Monitoring treatment strategies for patients treated in the UK and more widely.
Measured by analysis of samples from patients.
Time point - end of study.

Overall trial start date

01/06/2018

Overall trial end date

01/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age <18 years.
2. Confirmed diagnosis of cancer.
3. Patient receiving a ‘non-standard’ strategy of chemotherapy delivery (see below for examples of patient groups that fall into this category).*
4. Appropriate venous access.
5. Request from the treating clinician for therapeutic drug monitoring approach to treatment.
6. Willingness to participate and written informed parental/patient consent (signed and dated).

* Patients receiving non-standard chemotherapy dosing regimens will include the following groups: pre-term infants and neonates, anephric patients, patients receiving high dose myeloablative chemotherapy, patients undergoing chemoembolisation procedures, obese patients (BMI at or above the 95th percentile for children of the same age and sex).

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

150

Participant exclusion criteria

Failure to meet the inclusion criteria.

Recruitment start date

01/05/2019

Recruitment end date

30/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Aberdeen Children’s Hospital
Westburn Road
Aberdeen
AB25 2ZG
United Kingdom

Trial participating centre

Birmingham Children’s Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Trial participating centre

Bristol Royal Hospital for Children
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Trial participating centre

Children’s Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Royal Hospital for Sick Children, Edinburgh
Sciennes Road
Edinburgh
EH9 1LF
United Kingdom

Trial participating centre

Royal Hospital for Sick Children, Glasgow
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Trial participating centre

Leeds General Infirmary,
Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Alder Hey Children’s Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom

Trial participating centre

Royal Manchester Children’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Queens Medical Centre
Derby Rd
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

University College Hospital London
250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Newcastle Joint Research Office
Level 1
Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom
0191 282 5959
trust.r&d@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results will be reported and disseminated by the following methods;
Peer reviewed scientific journals
Internal reports
Conference presentation
Publication on website

A registry of information produced from the study will also be made available on the study website to guide clinicians in the treatment of 'hard to treat' patient groups.

Publication will be at the end of the study, with interim updates given throughout the study. The registry will be populated throughout the
study as information becomes available..

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Intention to publish date

01/05/2023

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/05/2019: Trial’s existence confirmed by NIHR.