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

Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05923567

Enrollment

150

Registered

2023-06-28

Start date

2021-02-18

Completion date

2024-12-31

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paancreatic Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
3yr overall survival	Survival period from surgery date, 3 years	3-year survival rate for patients who underwent surgery for pancreatic cancer

Secondary

Measure	Time frame	Description
1yr disease free survival	Period without recurrence from the date of surgery, one year	Recurrence rate in patients who have undergone surgery for pancreatic cancer within a year

Countries

South Korea

Outcome results