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.
