13-cis-retinoic acid monitoring study

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Paediatric Oncology; Disease: Miscellaneous; Cancer; Neuroblastoma

• Registration Number: ISRCTN37126758
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23087409 results (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-18
• Study Completion: 2015-03-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Age less than 18 years at time of registration, either sex
2. Diagnosis of high-risk neuroblastoma
3. Receiving 13-cis-retinoic acid (Roaccutane) as part of clinical treatment
4. Single or double lumen central venous catheter in place
5. Written informed consent
6. Protocol approval by national and local ethics committee, regulatory authority and Trust R&D Departments
7. A negative pregnancy test for women of childbearing potential, and sexually active patients and partners agreeing to undertake adequate contraceptive measures

Exclusion Criteria

Failure to comply with any of the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the feasibility of implementing dose individualisation with 13-cis-retinoic acid (Roaccutane) monitoring in patients undergoing treatment. All outcome measures will be measured upon completion of the study.

Secondary Outcome Measures

Name	Time	Method
<br> 1. To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of 13-cis-retinoic acid during long-term treatment<br> 2. To minimize the large inter-patient variation in plasma concentrations of 13-cis-retinoic observed following standard treatment with 13-cis-retinoic acid<br> 3. To obtain preliminary data to investigate the potential impact of 13-cis-retinoic therapeutic monitoring on efficacy and toxicity<br><br> All outcome measures will be measured upon completion of the study.<br>