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2021-02-18
2024-12-31
2024-12-31
150
NCT05923567
Gangnam Severance Hospital
Gangnam Severance Hospital
OBSERVATIONAL
New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-06-16 | N/A | 2024-02-05 |
2023-06-27 | N/A | 2024-02-07 |
2023-06-28 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 3yr overall survival | 3-year survival rate for patients who underwent surgery for pancreatic cancer | Survival period from surgery date, 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1yr disease free survival | Recurrence rate in patients who have undergone surgery for pancreatic cancer within a year | Period without recurrence from the date of surgery, one year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
