Dynamic Risk Prediction of Severe Myelosuppression in Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients with histologically confirmed nasopharyngeal carcinoma who require systemic anticancer treatment according to routine clinical practice will be prospectively enrolled from participating study centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,782 Participants
are grouped into 1 trial groupGroup A: Nasopharyngeal Carcinoma Cohort
Trial outcomes
Primary outcomes
1
Occurrence of Any Grade 3 or Higher Myelosuppression
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov