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Trial Title:
New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase
NCT ID:
NCT05923567
Condition:
Paancreatic Cancer
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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).
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Start date:
February 18, 2021
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Gangnam Severance Hospital
Agency class:
Other
Source:
Gangnam Severance Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05923567
