Biomarkers for Prediction of Tumor Response to Radiotherapy

Study Overview
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Brief Summary
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This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy

Detailed Description
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Patients pathologically confirmed with solid tumors that requires radiotherapy or surgery will be recruited to this study. Tumor samples were obtained from patients underwent surgery to establish the baseline status of biomarker assessed. Peripheral and microbiota will also be collected before and after surgery. For patients undergoing radiotherapy, tumor biopsy as well as collection of blood samples and microbiota will be performed during the course of treatment. These biological specimens will be used for assessment of tumor phenotypes and for exploration of potential biomarkers that could predict the tumor response to therapeutics and prognsis in patients with solid tumors.

Official Title
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Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors

Conditions
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Solid Tumors

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological proven diagnosis of solid tumors Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery Patient must provide study-specific informed consent prior to study entry Exclusion Criteria: History of autoimmune diseases History of immunotherapy Prior radiation therapy that would result in overlap of planned radiation therapy fields Will receive immunotherapy during the course of radiotherapy Contraindications for biopsy, such as high bleeding risk
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression status of biomarkers and their dynamic changes during treatment and follow-up | Expression status of biomarkers and their dynamic changes in patients' biological specimens through the course of treatment and during follow-up as assessed by a variety of means, including RNA-seq, DNA-seq, RT-qPCR, IHC, WB and ELISA. | From the date of enrollment until the date of disease progression, assessed up to 3 years | 
| Tumor short-term response to therapeutics | For patients treated with radiotherapy, shortly after the completion of treatment, the short-term response was assessed by using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) . | Within 1 month after the completion of radiotherapy | 
| Tumor long-term response to therapeutics | For patients treated with radiotherapy, tumor response was assessed by using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) . | up to 3 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific survival | The tumor disease-specific survival of patients | up to 3 years of follow-up |