Dynamic Risk Prediction of Severe Myelosuppression in Nasopharyngeal Carcinoma

NCT07819656 | Recruiting

• 1 other identifier: NFEC-2026-588
• Study Type: observational
• Target: 1,782
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma (NPC); Myelosuppression

Keywords

Dynamic Risk Prediction; Treatment-Related Myelosuppression

Outcome Measures

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.

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Jian Guan

CONTACT

+86-13632102247; 51643930@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)