Immune Score Based Radiomics in Nasopharyngeal Carcinoma

NCT05126160 | Recruiting

• 1 other identifier: ZJCH-2021-NPC01
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 5

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Immune Score Based Radiomics DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Renmin Hospital of Wuhan University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator

Study Sites (5)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Ningbo First Hospital

Ningbo, Ningbo, 315000, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Ningbo, 315000, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Wenzhou, 325000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Xiaozhong Chen

  Department of Radiation Oncology, Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaozhong Chen

CONTACT

0571-88128202; cxzfyun@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: November 18, 2021
• Study Start: November 5, 2021
• Primary Completion: October 1, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

CN (5)