Solid TumorsNCT03744819
Biomarkers for Prediction of Tumor Response to Radiotherapy
An observational study of Solid Tumors, run by Chuangzhen Chen at 1 site in China.
Trial summary
This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2018to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, 515031
Chuangzhen Chen, MD, 86-13923995569, stccz@139.com
Jianzhou Chen, MD, 86-13417049908, cjzeoeo@gmail.com
About this study
Official title: Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors
This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy
Read the 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.
- Conditions
- Solid Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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) .
Measured: 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) .
Measured: up to 3 years of follow-up
Secondary outcomes (1)
Disease-specific survival
The tumor disease-specific survival of patients
Measured: up to 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start29 Oct 2018
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuangzhen Chen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor-investigator, Chuangzhen Chen, Shantou University Medical College
- Investigators
- Chuangzhen Chen, MD, Principal investigator, Affiliated Cancer Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744819
- Sponsor's protocol ID
- IMRM2018
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2018
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT03744819
- Acronym / sponsor ID
- IMRM2018
- Conditions
- Solid Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chuangzhen ChenUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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) .
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) .
1 secondary outcome
Disease-specific survival
Time frame: up to 3 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuangzhen Chen, MD principal investigator
Affiliated Cancer Hospital of Shantou University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors, run by Chuangzhen Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuangzhen Chen, MD (+86 13923995569, stccz@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.