NCT05827471

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2023Dec 2026

First Submitted

Initial submission to the registry

March 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

March 26, 2023

Last Update Submit

April 21, 2023

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Tumor group

First diagnosis of colon cancer.

Diagnostic Test: Diagnosis of colon cancer

Control group

Healthy people.

Diagnostic Test: Diagnosis of colon cancer

Interventions

Diagnosis of colon cancerDIAGNOSTIC_TEST

Clinical diagnosis results

Control groupTumor group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Colon cancer was confirmed by colonoscopic pathology.
  • No local or systemic treatment was performed before operation.
  • Complete clinical data.

You may not qualify if:

  • Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp.
  • Other tumors other than colon cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and colon tissue samples.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 25, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 25, 2023

Record last verified: 2023-04