BiomarkerNCT06165224
A Bidirectional Cohort Study of COMMD10 Expression in Tumor Tissues for Predicting Radiosensitivity
An observational study of Biomarker and Radiosensitivity, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Radiotherapy is one of the main treatments for malignant tumors, and according to authoritative estimates, about 70% of patients with malignant tumors should receive radiotherapy. However, radiation resistance limits its application and clinical curative effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarker, Radiosensitivity
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have solid tumor and need radiotherapy
Who may be able to join
- At least 18 years old;
- Voluntarily sign informed consent;
- Nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer confirmed by pathology;
- Measurable tumor lesions according to RECIST v1.1 criteria;
- Patients with radiation therapy indications and voluntarily accept radiotherapy;
- ECOG PS score: 0/1.
Who cannot join
- There are contraindications to radiotherapy;
- Pathological sections could not be obtained;
- Presence of metal metabolism-related diseases such as Wilson's disease;
- Merge other tumors (has cured basal cell or squamous cell cancer, and cervical cancer in situ except 5);
- Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. "For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor health status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness;"
- The investigator judged that he was not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
About this study
Radiotherapy is one of the main treatments for malignant tumors, and according to authoritative estimates, about 70% of patients with malignant tumors should receive radiotherapy. However, radiation resistance limits its application and clinical curative effect. To find suitable radiation resistance markers and identify patients with radiation resistance, early part of the patients with appropriate radiotherapy sensitization agent or choose other more efficient and low toxicity of treatment, for improving the prognosis of patients, improve the quality of survival is of great significance, it is also the difficult point in the present study. However, there are no effective biomarkers to predict radiosensitivity. Through our previous basic research and analysis of clinical tumor tissues, we have found that the low expression of copper metabolism domain protein 10 (COMMD10) is associated with radioresistance, and COMMD10 is an effective marker for predicting radiosensitivity. We planned to conduct a single-center, prospective cohort study to verify the reliability of COMMD10 as a predictive marker for radiosensitivity in pan-cancer patients.
- Conditions
- Biomarker, Radiosensitivity
- Keywords
- copper metabolism domain protein 10, biomarker, radiosensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The objective response rate (ORR) is the proportion of patients who achieve a prespecified reduction in tumor volume that is maintained for a minimum duration. The objective response rate was defined as the sum of complete response plus partial response (CR+PR). According to RECIST1.1 criteria, CR was defined as the disappearance of target lesions and the reduction of the short diameter of pathological lymph nodes to less than 10mm. PR: the sum of the measured diameters of the target lesions reduced by 30% compared with the baseline; PD: the sum of the major diameters of all target lesions increased by at least 20%, and the absolute value of the sum of the major diameters increased by more than 5mm, or new lesions appeared. SD: Changes between PR and PD.
Measured: 1 month
Secondary outcomes (1)
Overall survival (OS)
OS was defined as the time from the date of inclusion until death from any cause.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165224
- Sponsor's protocol ID
- NFEC-2023-485
- Status last verified
- Mar 2024
- First submitted
- 3 Dec 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bidirectional Cohort Study of COMMD10 Expression in Tumor Tissues for Predicting Radiosensitivity
- ClinicalTrials.gov ID
- NCT06165224
- Acronym / sponsor ID
- NFEC-2023-485
- Conditions
- Biomarker, Radiosensitivity
- Keywords
- copper metabolism domain protein 10, biomarker, radiosensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Dec 2023 (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.
Radiotherapy is one of the main treatments for malignant tumors, and according to authoritative estimates, about 70% of patients with malignant tumors should receive radiotherapy. However, radiation resistance limits its application and clinical curative effect. To find suitable radiation resistance markers and identify patients with radiation resistance, early part of the patients with appropriate radiotherapy sensitization agent or choose other more efficient and low toxicity of treatment, for improving the prognosis of patients, improve the quality of survival is of great significance, it is also the difficult point in the present study. However, there are no effective biomarkers to predict radiosensitivity. Through our previous basic research and analysis of clinical tumor tissues, we have found that the low expression of copper metabolism domain protein 10 (COMMD10) is associated with radioresistance, and COMMD10 is an effective marker for predicting radiosensitivity. We planned to conduct a single-center, prospective cohort study to verify the reliability of COMMD10 as a predictive marker for radiosensitivity in pan-cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have solid tumor and need radiotherapy
Key inclusion criteria (6 listed)
- At least 18 years old;
- Voluntarily sign informed consent;
- Nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer confirmed by pathology;
- Measurable tumor lesions according to RECIST v1.1 criteria;
- Patients with radiation therapy indications and voluntarily accept radiotherapy;
Key exclusion criteria (6 listed)
- There are contraindications to radiotherapy;
- Pathological sections could not be obtained;
- Presence of metal metabolism-related diseases such as Wilson's disease;
- Merge other tumors (has cured basal cell or squamous cell cancer, and cervical cancer in situ except 5);
- Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. "For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor health status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness;"
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
Objective response rate (ORR)
Time frame: 1 month
The objective response rate (ORR) is the proportion of patients who achieve a prespecified reduction in tumor volume that is maintained for a minimum duration. The objective response rate was defined as the sum of complete response plus partial response (CR+PR). According to RECIST1.1 criteria, CR was defined as the disappearance of target lesions and the reduction of the short diameter of pathological lymph nodes to less than 10mm. PR: the sum of the measured diameters of the target lesions reduced by 30% compared with the baseline; PD: the sum of the major diameters of all target lesions increased by at least 20%, and the absolute value of the sum of the major diameters increased by more than 5mm, or new lesions appeared. SD: Changes between PR and PD.
1 secondary outcome
Overall survival (OS)
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Biomarker
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Not yet recruitingObservational study
Automated Capture of Core Data for Rare Diseases and Glucocorticoid Complications: Biomarkers and Patient-Reported Outcomes
Cushing s Syndrome, Glucocorticoid Effect
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. This study is not recruiting at the moment.
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 Biomarker and Radiosensitivity, run by Nanfang Hospital, Southern Medical University 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan, M.D. (+86-13632102247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1 month). 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 15 Mar 2024.