Biomarkers for Prediction of Tumor Response to Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors
Overview
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.
Primary outcome measures
- 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]
- Tumor short-term response to therapeutics [Time frame: Within 1 month after the completion of radiotherapy]
- Tumor long-term response to therapeutics [Time frame: up to 3 years of follow-up]
Secondary outcome measures (1)
- Disease-specific survival [Time frame: up to 3 years of follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Hospital, Shantou University Medical College — Shantou
Identifiers
NCT: NCT03744819 · IMRM2018