Carbohydrate Antigen 19-9 in Colorectal Cancer

NCT ID: NCT04999072

Last Updated: 2021-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4972 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-19

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Colectomy for colon cancer

Segmental or total colectomy was performed for colorectal cancer.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min Jung Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Jung Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Republic of Korea

Locations

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Seoul National University Hospital

Seoul, Jongnogu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH_CA19-9

Identifier Type: -

Identifier Source: org_study_id

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