Biomarkers for Prediction of Tumor Response to Radiotherapy

Recruiting

• Conditions: Solid Tumors

• Registration Number: NCT03744819
• Lead Sponsor: Chuangzhen Chen

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-10-29
• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor short-term response to therapeutics	Within 1 month after the completion of radiotherapy	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) .
Tumor long-term response to therapeutics	up to 3 years of follow-up	For patients treated with radiotherapy, tumor response was assessed by using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) .
Expression status of biomarkers and their dynamic changes during treatment and follow-up	From the date of enrollment until the date of disease progression, assessed up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Disease-specific survival	up to 3 years of follow-up	The tumor disease-specific survival of patients

Trial Locations

Locations (1)

Cancer Hospital, Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China