Clinical Study of QSOX1 as a Biomarker for Colon Cancer | NCT05827471

Studies
Clinical Study of QSOX1 as a Biomarker for Colon Cancer

NCT05827471

Sponsor

Qianfoshan Hospital

Status

Not yet recruiting

Last Update Posted

Apr 25, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Colon Cancer

Interventions

Diagnosis of colon cancer

Countries

Not provided

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Estimated

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 26, 2023

First Submission Date that Met QC Criteria

Apr 21, 2023

First Posted Date

Apr 25, 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

Apr 21, 2023

Last Update Posted Date

Apr 25, 2023Actual

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

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.

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tumor group		First diagnosis of colon cancer.	Diagnostic Test: Diagnosis of colon cancer
Control group		Healthy people.	Diagnostic Test: Diagnosis of colon cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnosis of colon cancer	Diagnostic Test	Clinical diagnosis results	Control group Tumor group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

The patients diagnosed with colon cancer for the first time admitted to the First Affiliated Hospital of Shandong First Medical University.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

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Browse Branches

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