COMPLETED

Microsampling Assays for Immunosuppressive Drugs in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Monitoring immunosuppressive drug (cyclosporine A, tacrolimus, and sirolimus) concentrations in the blood is important to ensure that the drug is given safely and effectively, but current approaches for collecting blood from a vein are painful and often difficult in children. Investigators seek to compare a new approach for monitoring immunosuppressive drug concentrations using a novel small volume blood sampling device, called Tasso-M20, to the traditional way of collecting blood from a vein. Additionally Investigators are interested in assessing patient and family perceptions of the Tasso-M20 device being used for immunosuppressive therapy and their comfortability using the device outside of a clinical setting. The primary objective of this project is to identify the relationship between cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) concentrations in the venous blood (gold-standard) and capillary whole blood obtained using the microsampling device Tasso-M20. The secondary objective of this study is to investigate the stability of CYA, TAC, and SIR in blood samples collected using the Tasso-M20 device under the conditions of shipping and storage. The sub-study objective is to thematically compare subjects' and families' perceptions of blood collection via the Tasso-M20 device and standard venous blood collection.

Official Title

Microsampling Assays for Immunosuppressive Drugs in Children

Quick Facts

Study Start:2023-06-08
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04989686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females \<18 years of age
  2. 2. Weight greater than 5 kg
  3. 3. Receiving CYA, TAC, and/or SIR as standard of care
  4. 4. Has scheduled/anticipated blood draw to quantify the concentration of CYA, TAC, and SIR\* for clinical indications
  5. 5. Parental/guardian permission (informed consent), and subject's assent if applicable.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Children's Hospital of Phildelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

  • microsampling
  • cyclosporine A
  • tacrolimus
  • sirolimus
  • Tasso-M20

Additional Relevant MeSH Terms

  • Immunosuppression