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2009-01-01
2023-12-31
2024-09-01
462
NCT06630481
Seoul National University Hospital
Seoul National University Hospital
OBSERVATIONAL
Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade
1. Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response. 2. Among various pathological tumor regression grading systems, the College of American Pathologists (CAP) system is commonly used to predict chemo-responsiveness and survival. 3. This study aimed to analyze long-term survival outcomes based on pathologic response using the CAP grade after NAT in PDAC and to identify clinicopathologic factors that influence a favorable pathologic response.
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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 |
|---|---|---|
2024-10-02 | N/A | 2024-10-05 |
2024-10-05 | N/A | 2024-10-08 |
2024-10-08 | N/A | 2024-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : CAP grade 0 No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy. | DRUG: neoadjuvant therapy
|
| : CAP grade 1 Single cells or rare small groups of cancer cells in pancreatic resection specimen with neoadjuvant therapy. | DRUG: neoadjuvant therapy
|
| : CAP grade 2 Residual cancer with evident tumor regression in pancreatic resection specimen with neoadjuvant therapy. | DRUG: neoadjuvant therapy
|
| : CAP grade 3 Extensive residual cancer with no evident tumor regression in pancreatic resection specimen with neoadjuvant therapy. | DRUG: neoadjuvant therapy
|
| : pathological complete response No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy. | DRUG: neoadjuvant therapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 5-year overall survival | from diagnosis to any cause of death | assessed up to 60months |
| 5-year disease-free survival | defined as the duration between the date of surgery and the occurrence of the first instance of recurrence, death, or the last follow-up date. | assessed up to 60months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
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
