Immune Score Based Radiomics in Nasopharyngeal Carcinoma

Recruiting

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT05126160
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-05
• Study First Submitted: 2021-11-07
• Study First Submitted QC: 2021-11-07
• Last Update Submitted: 2021-11-07
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Primary Completion: 2022-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 494

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	Median follow-up time of 5 years for the whole group	The AUC of the immune score based radiomic staging system

Trial Locations

Locations (5)

Ningbo Medical Center Lihuili Hospital; 🇨🇳 Ningbo, Ningbo, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Wenzhou, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Ningbo First Hospital; 🇨🇳 Ningbo, Ningbo, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China