Immune Score Based Radiomics in Nasopharyngeal Carcinoma

Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Diagnostic test: Immune Score Based Radiomics

• Study Type: Observational
• Enrollment (Anticipated): 494

Contacts and Locations

• Study Contact: Name: Xiaozhong Chen; Phone Number: +86 0571-88128202; Email: cxzfyun@sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Xiangpan Li; Email: rm001227@whu.edu.cn
      • Principal Investigator: Xiangpan Li
      • Sub-Investigator: Qingqing Li
  • Ningbo
    • Ningbo, Ningbo, China, 315000
      • Recruiting
      • Ningbo First Hospital
      • Principal Investigator: Pengrong Lou
      • Sub-Investigator: Jianliang Zhou
    • Ningbo, Ningbo, China, 315000
      • Recruiting
      • Ningbo Medical Center Lihuili Hospital
      • Contact: Miaozhen Lu; Email: lmz2005@yeah.net
      • Principal Investigator: Miaozhen Lu
      • Sub-Investigator: Yanping Bei
  • Wenzhou
    • Wenzhou, Wenzhou, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Changlin Zou; Email: zcl19670115@163.com
      • Principal Investigator: Changlin Zou
      • Sub-Investigator: Raoying Xie
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Xiaozhong Chen; Phone Number: +86 571-88128202; Email: cxzfyun@sina.com
      • Sub-Investigator: Caineng Cao
      • Sub-Investigator: Lei Wang
      • Sub-Investigator: Shuang Huang
      • Sub-Investigator: Mengyun Qiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Non-metastatic NPC patients receive radical radiotherapy with/without induction or concurrent chemotherapy. De novo metastatic NPC patients would receive at least 4 cycles of platinum-based therapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Ningbo Medical Center Lihuili Hospital; Renmin Hospital of Wuhan University; First Affiliated Hospital of Wenzhou Medical University; Ningbo No. 1 Hospital
• Investigators: Principal Investigator: Xiaozhong Chen, Department of Radiation Oncology, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: November 7, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: ZJCH-2021-NPC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No