Colon CancerNCT05827471
Clinical Study of QSOX1 as a Biomarker for Colon Cancer
An observational study of Colon Cancer, run by Qianfoshan Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Diagnosis of colon cancer
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients diagnosed with colon cancer for the first time admitted to the First Affiliated Hospital of Shandong First Medical University.
Who may be able to join
- Colon cancer was confirmed by colonoscopic pathology.
- No local or systemic treatment was performed before operation.
- Complete clinical data.
Who cannot join
- Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp.
- Other tumors other than colon cancer.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Diagnosis of colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of colon cancerDiagnostic test
Clinical diagnosis results
| Study group | Role | What they receive |
|---|---|---|
| Tumor group | First diagnosis of colon cancer. Receives: Diagnostic Test: Diagnosis of colon cancer | |
| Control group | Healthy people. Receives: Diagnostic Test: Diagnosis of colon cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of RNA for early rapid diagnosis of colon cancer.
RT-PCR was used to detect the RNA levels of QSOX1 in the tumor and control groups.
Measured: 6 months
Detection of protein for early rapid diagnosis of colon cancer.
Western blotting was used to detect the protein levels of QSOX1 in the tumor and control groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YunqiuWang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827471
- Sponsor's protocol ID
- QianfoshanHwyq20230305
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Sulfhydryl Oxidase QSOX1 as a New Biomarker of Colon Cancer
- ClinicalTrials.gov ID
- NCT05827471
- Acronym / sponsor ID
- QianfoshanHwyq20230305
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor group | – | Diagnostic Test: Diagnosis of colon cancerFirst diagnosis of colon cancer. |
| Control group | – | Diagnostic Test: Diagnosis of colon cancerHealthy people. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients diagnosed with colon cancer for the first time admitted to the First Affiliated Hospital of Shandong First Medical University.
Key inclusion criteria (3 listed)
- Colon cancer was confirmed by colonoscopic pathology.
- No local or systemic treatment was performed before operation.
- Complete clinical data.
Key exclusion criteria (2 listed)
- Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp.
- Other tumors other than colon cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of colon cancerClinical diagnosis results | Diagnostic test | Control group, Tumor group |
Primary outcome
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.
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.
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 25 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Qianfoshan Hospital.
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 2 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: opening soon, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of RNA for early rapid diagnosis of colon cancer. (time frame: 6 months). The study lists 2 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 25 Apr 2023.