- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05827471
Clinical Study of QSOX1 as a Biomarker for Colon Cancer
April 21, 2023 updated by: YunqiuWang, Qianfoshan Hospital
Clinical Application of Sulfhydryl Oxidase QSOX1 as a New Biomarker of Colon Cancer
The goal of this observational study is to determine whether the secreted protein QSOX1 can be used as a molecular marker for early rapid diagnosis and accurate treatment of colon cancer.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The project mainly selects the tumor group represented by colon cancer and the corresponding healthy people as the control group, with about 100 cases in each of the two groups.
Mainly collect blood and tumor tissue samples of patients, detect the expression of QSOX1 in the above samples, and explore the role in the diagnosis and prognosis evaluation of colon cancer.
Study Type
Observational
Enrollment (Anticipated)
400
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The patients diagnosed with colon cancer for the first time admitted to the First Affiliated Hospital of Shandong First Medical University.
Description
Inclusion Criteria:
- Colon cancer was confirmed by colonoscopic pathology.
- No local or systemic treatment was performed before operation.
- Complete clinical data.
Exclusion Criteria:
- Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp.
- Other tumors other than colon cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Tumor group
First diagnosis of colon cancer.
|
Clinical diagnosis results
|
|
Control group
Healthy people.
|
Clinical diagnosis results
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of RNA for early rapid diagnosis of colon cancer.
Time Frame: 6 months
|
RT-PCR was used to detect the RNA levels of QSOX1 in the tumor and control groups.
|
6 months
|
|
Detection of protein for early rapid diagnosis of colon cancer.
Time Frame: 6 months
|
Western blotting was used to detect the protein levels of QSOX1 in the tumor and control groups.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2023
Primary Completion (Anticipated)
June 30, 2026
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
March 26, 2023
First Submitted That Met QC Criteria
April 21, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QianfoshanHwyq20230305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.