Pancreatic CancerCAP with NATNCT06630481
Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade
An observational study of Pancreatic Cancer and Neoadjuvant Therapy, run by Seoul National University Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer, Neoadjuvant Therapy, Pathological Complete Response
- What is being tested?
- neoadjuvant therapy
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients (aged \>18 years) who underwent pancreatic resection after NAT at Seoul National University Hospital between January 2009 and December 2023 were included. Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.
Who may be able to join
- Adult patients (aged \>18 years) who underwent pancreatic resection after NAT at a single center between January 2009 and December 2023.
- Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.
Who cannot join
- Patients without a reported CAP grade
- Patients who underwent palliative surgery
- Patients who received NAT outside the specified protocol due to incomplete information.
About this study
- Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response.
- Among various pathological tumor regression grading systems, the College of American Pathologists (CAP) system is commonly used to predict chemo-responsiveness and survival.
- 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.
- Being tested
- neoadjuvant therapy
- Keywords
- CAP grade, tumor response grading system
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.
| Study group | Role | What they receive |
|---|---|---|
| CAP grade 0 | No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy. Receives: Drug: neoadjuvant therapy | |
| CAP grade 1 | Single cells or rare small groups of cancer cells in pancreatic resection specimen with neoadjuvant therapy. Receives: Drug: neoadjuvant therapy | |
| CAP grade 2 | Residual cancer with evident tumor regression in pancreatic resection specimen with neoadjuvant therapy. Receives: Drug: neoadjuvant therapy | |
| CAP grade 3 | Extensive residual cancer with no evident tumor regression in pancreatic resection specimen with neoadjuvant therapy. Receives: Drug: neoadjuvant therapy | |
| pathological complete response | No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy. Receives: Drug: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
from diagnosis to any cause of death
Measured: 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.
Measured: assessed up to 60months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2009
- Primary completion31 Dec 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630481
- Sponsor's protocol ID
- 2407-036-1558
- Acronym
- CAP with NAT
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade
- ClinicalTrials.gov ID
- NCT06630481
- Acronym / sponsor ID
- CAP with NAT / 2407-036-1558
- Keywords
- CAP grade, tumor response grading system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response.
- Among various pathological tumor regression grading systems, the College of American Pathologists (CAP) system is commonly used to predict chemo-responsiveness and survival.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CAP grade 0 | – | Drug: neoadjuvant therapyNo viable cancer cells in pancreatic resection specimen with neoadjuvant therapy. |
| CAP grade 1 | – | Drug: neoadjuvant therapySingle cells or rare small groups of cancer cells in pancreatic resection specimen with neoadjuvant therapy. |
| CAP grade 2 | – | Drug: neoadjuvant therapyResidual cancer with evident tumor regression in pancreatic resection specimen with neoadjuvant therapy. |
| CAP grade 3 | – | Drug: neoadjuvant therapyExtensive residual cancer with no evident tumor regression in pancreatic resection specimen with neoadjuvant therapy. |
| pathological complete response | – | Drug: neoadjuvant therapyNo viable cancer cells in pancreatic resection specimen with neoadjuvant therapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients (aged \>18 years) who underwent pancreatic resection after NAT at Seoul National University Hospital between January 2009 and December 2023 were included. Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.
Key inclusion criteria (2 listed)
- Adult patients (aged \>18 years) who underwent pancreatic resection after NAT at a single center between January 2009 and December 2023.
- Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.
Key exclusion criteria (3 listed)
- Patients without a reported CAP grade
- Patients who underwent palliative surgery
- Patients who received NAT outside the specified protocol due to incomplete information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant therapyNeoadjuvant chemotherapy, neoadjuvant radiotherapy, or both. | Drug | CAP grade 0, CAP grade 1, CAP grade 2, CAP grade 3, pathological complete response |
Primary outcome
5-year overall survival
Time frame: assessed up to 60months
from diagnosis to any cause of death
5-year disease-free survival
Time frame: assessed up to 60months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Neoadjuvant Therapy, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: assessed up to 60months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.