Dynamic Risk Prediction of Severe Myelosuppression in Nasopharyngeal Carcinoma

NCT07819656 — Recruiting, 1782 participants, Nanfang Hospital, Southern Medical University

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A Multicenter, Prospective, Observational Cohort Study of a Dynamic Risk Prediction Model for Treatment-Related Severe Myelosuppression in Nasopharyngeal Carcinoma

Registry	NCT07819656
Status	Recruiting
Study type	Observational
Enrollment	1782 (Estimated)
Sponsor	Nanfang Hospital, Southern Medical University (Other)
Conditions	Nasopharyngeal Carcinoma (NPC), Myelosuppression
Dates	start 2026-08-26, primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-09-15, last updated 2026-09-15
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Nasopharyngeal Carcinoma Cohort			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.

+Outcome measures

Primary outcomes

Occurrence of Any Grade 3 or Higher Myelosuppression [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.]: 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

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Nanfang Hospital, Southern Medical University	Guangzhou, Guangdong	China	Recruiting