Clinical trial NCT06165224: A Bidirectional Cohort Study of COMMD10 Expression in Tumor Tissues for Predicting Radiosensitivity
Official title: A Bidirectional Cohort Study of COMMD10 Expression in Tumor Tissues for Predicting Radiosensitivity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biomarker
Radiosensitivity
Keywords: copper metabolism domain protein 10
biomarker
radiosensitivity
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients have solid tumor and need radiotherapy

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old;
2. Voluntarily sign informed consent;
3. 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;
4. Measurable tumor lesions according to RECIST v1.1 criteria;
5. Patients with radiation therapy indications and voluntarily accept radiotherapy;
6. ECOG PS score: 0/1.

Exclusion Criteria:

1. There are contraindications to radiotherapy;
2. Pathological sections could not be obtained;
3. Presence of metal metabolism-related diseases such as Wilson's disease;
4. Merge other tumors (has cured basal cell or squamous cell cancer, and cervical cancer in situ except 5);
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;"
6. The investigator judged that he was not suitable to participate in the study.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 1 month
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 1 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern medical university
state: Guangdong
Study officials:
References: