Biomarkers for Prediction of Tumor Response to Radiotherapy

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03744819
• Other study ID #: IMRM2018
• Status: Recruiting
• Start date: October 29, 2018
• Est. completion date: November 30, 2026

Study information

• Verified date: February 2024
• Source: Shantou University Medical College
• Contact: Chuangzhen Chen, MD
• Phone: +86 13923995569
• Email: stccz[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Locations

Country	Name	City	State
China	Cancer Hospital, Shantou University Medical College	Shantou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Chuangzhen Chen	University of Oxford

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	The overall survival of patients	up to 3 years of follow-up
Primary	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
Primary	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
Primary	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	Disease-specific survival	The tumor disease-specific survival of patients	up to 3 years of follow-up