Immune Score Based Radiomics in Nasopharyngeal Carcinoma

November 7, 2021 updated by: Zhejiang Cancer Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
        • 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:
        • Principal Investigator:
          • Miaozhen Lu
        • Sub-Investigator:
          • Yanping Bei
    • Wenzhou
      • Wenzhou, Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Principal Investigator:
          • Changlin Zou
        • Sub-Investigator:
          • Raoying Xie
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Sub-Investigator:
          • Caineng Cao
        • Sub-Investigator:
          • Lei Wang
        • Sub-Investigator:
          • Shuang Huang
        • Sub-Investigator:
          • Mengyun Qiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Time Frame: Median follow-up time of 5 years for the whole group
The AUC of the immune score based radiomic staging system
Median follow-up time of 5 years for the whole group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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