Clinical trial · Observational
Long-term Outcomes for Acute Myeloid Leukemia Patients
A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
NCT03755856CI-TRIAL-000437701621-QLG-LGunknownClinicalTrials.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)
This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of differences in SF-36 scores
- timeFrame
- At enrollment
- description
- The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population.
Secondary outcomes (4)
- measure
- Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
- timeFrame
- At enrollment
- description
- Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores
- measure
- QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20% blasts in the bone marrow), except acute promyelocytic leukemia (APL). * Age at AML diagnosis ≥ 18 years, * Date of AML diagnosis at least 5 years before study enrollment, * AML-free status at study enrollment, * Written informed consent provided. Exclusion Criteria: * Major cognitive deficit or psychiatric problems hampering a self-reported evaluation, * Not speaking and reading the language of the participating country, * More than 75 years at the time of study enrollment, * Receiving any active treatment for AML at the time of study enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.