New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase

NCT ID: NCT05923567

Last Updated: 2024-02-07

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

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-18

Study Completion Date

2024-12-31

Brief Summary

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Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6

Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.

Detailed Description

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Conditions

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Paancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CA19-9<385 & FE-1>100

No interventions assigned to this group

CA19-9<385 and FE-1>100

No interventions assigned to this group

CA19-9>385 & FE-1>100

No interventions assigned to this group

CA19-9>385 & FE-1<100

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.

Exclusion Criteria

* Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels \< 9.0 \[Lewis antibody-negative patients\] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung Sun Kim

Assoiciate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2020-0522

Identifier Type: -

Identifier Source: org_study_id

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