Therapeutic drug monitoring in children with cancer
| ISRCTN | ISRCTN10139334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10139334 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NCCPG TDM 2018 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 09/05/2019
- Registration date
- 10/05/2019
- Last edited
- 19/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-measuring-the-levels-of-chemotherapy-in-the-blood-nccpg-tdm-2018 (added 23/04/2020)
Contact information
Scientific
Northern Institute for Cancer Research
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0002-1897-8678 |
|---|---|
| Phone | +44 (0)191 208 4332 |
| g.j.veal@newcastle.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre basic science study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | A clinical pharmacology study to investigate the utility of therapeutic drug monitoring in challenging childhood cancer patient populations |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/06/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 168 |
| Key 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). |
| Key exclusion criteria | Failure to meet the inclusion criteria. |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 30/11/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centres
Aberdeen
AB25 2ZG
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Cambridge
CB2 2QQ
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Edinburgh
EH9 1LF
United Kingdom
Glasgow
G51 4TF
United Kingdom
London
WC1N 3JH
United Kingdom
Leeds
LS1 3EX
United Kingdom
Liverpool
L12 2AP
United Kingdom
Manchester
M13 9WL
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Sheffield
S10 2TH
United Kingdom
Southampton
SO16 6YD
United Kingdom
London
NW1 2PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/11/2024 | 19/11/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/11/2024: Publication reference and total final enrolment added.
08/11/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 30/11/2023 to 30/11/2028.
2. The overall study end date was changed from 01/06/2024 to 01/06/2029.
3. The intention to publish date was changed from 01/12/2024 to 01/12/2029.
4. Study website added.
05/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2022 to 30/11/2023.
2. The overall trial end date has been changed from 01/11/2022 to 01/06/2024.
3. The intention to publish date has been changed from 01/05/2023 to 01/12/2024.
23/04/2020: Added link to plain English summary on Cancer Reseach UK website.
08/11/2019: Internal review.
05/08/2019: Internal review.
21/06/2019: Internal review.
09/05/2019: Trial’s existence confirmed by NIHR.
