Biomarkers for Prediction of Tumor Response to Radiotherapy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03744819

Enrollment

100

Registered

2018-11-16

Start date

2018-10-29

Completion date

2026-11-30

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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) .

Secondary

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

Other

Measure	Time frame	Description
Overall survival	up to 3 years of follow-up	The overall survival of patients

Countries

China

Contacts

Primary ContactChuangzhen Chen, MD

stccz@139.com+86 13923995569

Outcome results