Biomarkers for Prediction of Tumor Response to Radiotherapy

NCT03744819 | Recruiting

• 1 other identifier: IMRM2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Disease-specific survival

  up to 3 years of follow-up

Other Outcomes (1)

• Overall survival

  up to 3 years of follow-up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients proven diagnosis of solid tumors and will have radiotherapy as part of their therapeutic regimens or will undergo surgery in Cancer Hospital of Shantou University Medical College.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuangzhen Chen: lead
• University of Oxford: collaborator

Study Sites (1)

Cancer Hospital, Shantou University Medical College

Shantou, Guangdong, 515031, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples, peripheral blood and microbiota

Study Officials

• Chuangzhen Chen, MD

  Affiliated Cancer Hospital of Shantou University Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuangzhen Chen, MD

CONTACT

+86 13923995569; stccz@139.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 16, 2018
• Study Start: October 29, 2018
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CN (1)