Carbohydrate Antigen 19-9 in Colorectal Cancer

Sponsor
Seoul National University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04999072
Collaborator
(none)
4,972
1
19.4
256.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Colectomy for colon cancer

Detailed Description

Introduction: Carcinoembryonic antigen (CEA) is a main prognostic marker and can detect colorectal cancer (CRC) recurrence, but it has low sensitivity. Carbohydrate antigen 19-9 (CA19-9) can be used as a supplemental tumour marker along with CEA. This study investigated the utility of preoperative and follow-up serum CA19-9 assessment for CRC.

Materials and Methods: We retrospectively assessed 4,972 patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital. Data on demographics, preoperative and follow-up CEA and CA19-9 levels, recurrence, and survival were obtained and analysed with respect to tumour marker levels to ascertain their prognostic and diagnostic values.

Results: The 5-year relapse-free survival rates were 72.2±0.8%, 52.5±2.2%, 55.5±3.2%, and 32.1±2.3% in the normal CEA and CA19-9, high CEA, high CA19-9, and high CEA and high CA19-9 groups, respectively (all p<0.001). Patients whose elevated CEA or CA19-9 reduced to normal had better survival outcomes than those with postoperatively elevated levels. Elevated follow-up CA19-9 and CEA levels were related to higher incidences of distant metastasis (CA19-9: 14.0% vs. 23.1%, p=0.004, CEA: 12.6% vs. 30.1%, p<0.001) but not with local recurrence. Combined follow-up CEA and CA19-9 increased the sensitivity for recurrence to 31.4%, with a 5% difference compared with CEA alone. In the subgroup with high preoperative CA19-9 levels, sensitivity increased by 18.2% overall.

Conclusion: 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.

Study Design

Study Type:
Observational
Actual Enrollment :
4972 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Carbohydrate Antigen 19-9 Plus Carcinoembryonic Antigen for Prognosis in Colorectal Cancer
Actual Study Start Date :
Apr 19, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Relapse free survival [5-year]

    Recurrence and death was the event for relapse free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital
Exclusion Criteria:
  • The patients with missing data for preoperative and follow-up tumour markers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Jongnogu Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Min Jung Kim, M.D., Seoul National University Hospital, Republic of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min Jung Kim, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04999072
Other Study ID Numbers:
  • SNUH_CA19-9
First Posted:
Aug 10, 2021
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2021