Clinical trial · Observational
N-PhenoGENICS: Neurocognitive-Phenome, Genome, Epigenome and Nutriome In Childhood Leukemia Survivors
NCT01913093CI-TRIAL-00047587NPGcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To find possible therapeutic targets to help prevent long-term brain and behavioural side effects in survivors of childhood leukemia that may have been caused by chemotherapy (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is that genetic variations of the elements in the folate-related cycles and methotrexate disposition networks are associated with the deficit phenotype (TRANCE) of childhood leukemia survivors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Leukemia Survivors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Leukemia survivors with neurocognitive deficit
- description
- Leukemia survivors with neuro-cognitive deficit phenotype. Based on DIVERGET and other phenotyping tools, we will identify those with the deficit phenotype. This will be treated as "case".
- label
- Leukemia survivors without neurocognitive deficit
- description
- Leukemia survivors who did not show impaired neurocognitive function, compared to the Control group defined above.
Primary outcomes (4)
- measure
- DIVERGET
- timeFrame
- Within 6 months from the enrolment
- description
- This is a short battery of tests that has been shown to be predictive of both global and academic impairment in survivors of childhood cancer. All neuro-cognitive tests are done on a same day.
- measure
- Stop Signal Task (SST)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Past diagnosis of acute lymphoblastic leukemia * 8 years : 0 months - 20 years : 11 months old at the time of their study visit * At least 2 years : 0 months from the last treatment for acute lymphoblastic leukemia at the time of their study visit * Continuous complete remission and undergone no bone marrow transplantation or cranial radiation therapy * Fluent in English (a subject and one parent) for test completion * Signed informed consent Exclusion Criteria: * Inability to complete the phenotyping tests * Down Syndrome diagnosis
References
Publications (0)
Data not yet available
No reference posted for this study.