Nasopharyngeal Carcinoma Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 494 |
| Est. completion date | December 2027 |
| Est. primary completion date | October 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Ningbo First Hospital | Ningbo | Ningbo |
| China | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Zhejiang Cancer Hospital | First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Ningbo No. 1 Hospital, Renmin Hospital of Wuhan University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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