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Recruiting

NCT Number: NCT03744819

Biomarkers for Prediction of Tumor Response to Radiotherapy

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

Recruiting

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Key information

Conditions

Solid Tumors

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Expression status of biomarkers and their dynamic changes during treatment and follow-up

    Time frame: 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.

  2. Tumor short-term response to therapeutics

    Time frame: 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) .

  3. Tumor long-term response to therapeutics

    Time frame: 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 outcomes

  1. Disease-specific survival

    Time frame: up to 3 years of follow-up

    The tumor disease-specific survival of patients

Other outcomes

  1. Overall survival

    Time frame: up to 3 years of follow-up

    The overall survival of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Chuangzhen Chen, MD

CONTACT

[email protected]

+86 13923995569

Sponsors and collaborators

Lead sponsor

Chuangzhen Chen

Other

Collaborators

  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Nov 16, 2018
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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