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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04999072
Other study ID # SNUH_CA19-9
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 19, 2020
Est. completion date December 1, 2021

Study information

Verified date August 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4972
Est. completion date December 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Colectomy for colon cancer
Segmental or total colectomy was performed for colorectal cancer.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongnogu

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse free survival Recurrence and death was the event for relapse free survival 5-year
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