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

Yonsei University Health System (YUHS)

Status: Active, not recruiting

Conditions: Paancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05923567

3-2020-0522

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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).

Trial design

150 participants in 4 patient groups

CA19-9<385 & FE-1>100

CA19-9<385 and FE-1>100

CA19-9>385 & FE-1>100

CA19-9>385 & FE-1<100