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Immune Score Based Radiomics in Nasopharyngeal Carcinoma

NCT ID: NCT05126160

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-05

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Immune Score Based Radiomics

To establish an immune score based radiomic staging system for nasopharyngeal carcinoma

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaozhong Chen

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Zhejiang Cancer Hospital

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Ningbo First Hospital

Ningbo, Ningbo, China

Site Status RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Ningbo, China

Site Status RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Wenzhou, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaozhong Chen

Role: CONTACT

Phone: 0571-88128202

Email: [email protected]

Facility Contacts

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Xiangpan Li

Role: primary

Pengrong Lou

Role: primary

Miaozhen Lu

Role: primary

Changlin Zou

Role: primary

Xiaozhong Chen

Role: primary

Other Identifiers

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ZJCH-2021-NPC01

Identifier Type: -

Identifier Source: org_study_id