NCT05204433

Brief Summary

In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1\_16\_17\_18 CpG site was good performance as a diagnostic marker of colorectal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 5, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

January 11, 2022

Last Update Submit

January 11, 2022

Conditions

Early Diagnosis of Colorectal Cancer and Adenoma

Outcome Measures

Primary Outcomes (1)

  • effectiveness of methylation markers from stool samples

    assess the effectiveness of methylation markers from stool samples in colon cancer patients, colorectal adenoma patients, compared with normal volunteers

    3 years

Secondary Outcomes (1)

  • assess the capacities of RF model in screening potential clinical biomarkers.

    3 years

Study Arms (4)

normal control

healthy volunteers

Other: no intervention

adenoma

pathologically reported colorectal adenoma

Other: no intervention

colorectcal cancer

pathologically reported colon cancers

Other: no intervention

High risk group

pathologically reported inflammatory bowel diseases

Interventions

no interventionOTHER

no intervention

adenomacolorectcal cancernormal control

Eligibility Criteria

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

consecutive adult patients undergoing an outpatient endoscopy

You may qualify if:

  • consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled.

You may not qualify if:

  • Lynch syndrome
  • Familial adenomatous polyposis
  • MUTYH associated polyposis
  • Peutz-Jeghers syndrome
  • Juvenile polyposis syndrome
  • Serrated polyposis syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jie Liang

Xi'an, Shaanxi, 710012, China

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 24, 2022

Study Start

January 5, 2019

Primary Completion

February 20, 2022

Study Completion

March 30, 2022

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

CN(1)