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Recruiting NCT05126160

Immune Score Based Radiomics in Nasopharyngeal Carcinoma

Observational Nasopharyngeal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immune Score Based Radiomics.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)

Overview

In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.

Interventions

  • Diagnostic test Immune Score Based Radiomics
    To establish an immune score based radiomic staging system for nasopharyngeal carcinoma

Primary outcome measures

  • Area Under Curve (AUC) [Time frame: Median follow-up time of 5 years for the whole group]

Eligibility criteria

Inclusion criteria

Patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.

ECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC >4\*109/L, HGB>90G/L, and PLT>100\*109/L. Written informed consent

Exclusion criteria

Contraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), or emotional disturbance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • Renmin Hospital of Wuhan University — Wuhan
  • Ningbo First Hospital — Ningbo
  • Ningbo Medical Center Lihuili Hospital — Ningbo
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT05126160 · ZJCH-2021-NPC01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗