Clinical trial · Observational
Dynamic Risk Prediction of Severe Myelosuppression in Nasopharyngeal Carcinoma
A Multicenter, Prospective, Observational Cohort Study of a Dynamic Risk Prediction Model for Treatment-Related Severe Myelosuppression in Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This multicenter, prospective, observational cohort study aims to evaluate a previously developed dynamic risk prediction model for severe treatment-related myelosuppression in patients with nasopharyngeal carcinoma receiving systemic therapy. The model is designed to estimate the risk of grade 3 or higher anemia, thrombocytopenia, and leukopenia or neutropenia during treatment. Eligible adult patients with histologically confirmed nasopharyngeal carcinoma will be consecutively enrolled at participating centers. Before each cycle of systemic therapy, routinely available clinical and laboratory data will be collected and used to generate updated risk predictions. Patients will be followed throughout systemic therapy and for 28 days after the last treatment. This is an observational study. Treatment and supportive care will be determined by treating physicians according to routine clinical practice. Model predictions will be used only for research evaluation and will not be used to guide or modify patient treatment. The study will evaluate the predictive performance and clinical applicability of the model across multiple centers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelosuppression | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma (NPC) | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Nasopharyngeal Carcinoma Cohort
- description
- Adult patients with histologically confirmed nasopharyngeal carcinoma receiving systemic anticancer therapy as part of routine clinical care will be prospectively enrolled. Clinical and laboratory data will be collected longitudinally during treatment to evaluate the performance of a previously developed dynamic risk prediction model for grade 3 or higher treatment-related myelosuppression. Treatment decisions will not be determined or modified by the study.
Primary outcomes (1)
- measure
- Occurrence of Any Grade 3 or Higher Myelosuppression
- timeFrame
- During each 21-day systemic treatment cycle, from the start of the cycle until the start of the next cycle; for the final cycle, through 28 days after the final systemic treatment.
- description
- Occurrence of any grade 3 or higher treatment-related myelosuppression, including anemia, thrombocytopenia, leukopenia, or neutropenia, as assessed during each systemic treatment cycle and after the final systemic treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary provision of written informed consent. * Age ≥18 years. * Histologically confirmed nasopharyngeal carcinoma. * Patients who, in the judgment of the treating physician, require systemic anticancer treatment. Exclusion Criteria: * Presence of other uncontrolled serious diseases, including unstable cardiac disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose \>1.5 times the upper limit of normal), psychiatric disorders, or a history of severe allergy. * Considered unsuitable for participation in the study by the investigator.
References
Publications (0)
Data not yet available