A Bidirectional Cohort Study of COMMD10 Expression in Tum... | NCT06165224

Studies
A Bidirectional Cohort Study of COMMD10 Expression in Tumor Tissues for Predicting Radiosensitivity

NCT06165224

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Biomarker
Radiosensitivity

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Dec 3, 2023

First Submission Date that Met QC Criteria

Dec 3, 2023

First Posted Date

Dec 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 month

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	OS was defined as the time from the date of inclusion until death from any cause.	1 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients have solid tumor and need radiotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jian Guan, M.D.	Contact	+86-13632102247		guanjian5461@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang hospital, Southern medical university	Recruiting	Guangzhou	Guangdong	510515	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided