NCT04999072

Brief Summary

4,972 patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital were retrospectively reviewed. CA19-9 is a valuable prognostic and diagnostic marker for CRC when used adjunctively with CEA and can be a supplementary marker with CEA to improve sensitivity, especially with elevated preoperative CA19-9.

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
4,972

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

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

April 19, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

August 3, 2021

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relapse free survival

    Recurrence and death was the event for relapse free survival

    5-year

Interventions

Segmental or total colectomy was performed for colorectal cancer.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This single-centre retrospective study was based on the analysis of information from a prospectively maintained database of CRC in Seoul National University Hospital (SNUH CRC DB). Data were extracted from the SNUH CRC DB for patients who underwent surgery for primary CRC between January 2004 and December 2015 at our institution. The patients with missing data for preoperative and follow-up tumour markers were excluded from the analysis. This study was approved by the Institutional Review Board of Seoul National University Hospital (SNUH IRB; IRB no. 2007-014-1138). The approving authority waived the requirement for written informed consent owing to the retrospective study design.

You may qualify if:

  • patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital

You may not qualify if:

  • The patients with missing data for preoperative and follow-up tumour markers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Min Jung Kim, M.D.

    Seoul National University Hospital, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 10, 2021

Study Start

April 19, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations