Pancreatic Ductal AdenocarcinomaNCT06320717
AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma
An observational study of Pancreatic Ductal Adenocarcinoma, run by Roswell Park Cancer Institute at 2 sites in United States.
Trial summary
To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel. The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Blood sample
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2024to 2 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community practices and hospital clinics
Who may be able to join
- Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria [35].
- Availability of archival tumor tissue (diagnostic for PDAC) required
- Have a documented ECOG Performance Status of ≤ 1
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.
Who cannot join
- Has received prior systemic treatment (standard of care or experimental) for PDAC
- Participant has a concurrent malignancy requiring active treatment during the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
- Recruiting
Good Samaritan University Hospital
West Islip, New York, 11795
John Loscalzo, MD, 631-417-8600
John Loscalzo, MD
About this study
Official title: A Retrospective/Prospective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma
To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.
The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with Borderline Resectable (Cohort A) | Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy Receives: Other: Blood sample | |
| Patients with Resectable (Cohort B) | Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective prediction of pCR in resectable patients
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended
Measured: Up to 2 years
Retrospective prediction of pCR in borderline resectable patients
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended).
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended)
Measured: Up to 2 years
Secondary outcomes (2)
Survival status
Medical chart will be reviewed for survival status
Measured: Up to 2 years
RECIST 1.1 response
Tumor response was determined by RECIST1.1
Measured: UP to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start2 Jan 2024
- Primary completion2 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christos Fountilas, MD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320717
- Sponsor's protocol ID
- I-3574823
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective/Prospective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06320717
- Acronym / sponsor ID
- I-3574823
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 20 Mar 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.
To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.
The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Borderline Resectable (Cohort A) | – | Other: Blood samplePathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy |
| Patients with Resectable (Cohort B) | – | Other: Blood samplePathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community practices and hospital clinics
Key inclusion criteria (4 listed)
- Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria [35].
- Availability of archival tumor tissue (diagnostic for PDAC) required
- Have a documented ECOG Performance Status of ≤ 1
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.
Key exclusion criteria (2 listed)
- Has received prior systemic treatment (standard of care or experimental) for PDAC
- Participant has a concurrent malignancy requiring active treatment during the study.
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 |
|---|---|---|
| Blood sampleTo determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients | Other | Patients with Borderline Resectable (Cohort A), Patients with Resectable (Cohort B) |
Primary outcome
Retrospective prediction of pCR in resectable patients
Time frame: Up to 2 years
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended
Retrospective prediction of pCR in borderline resectable patients
Time frame: Up to 2 years
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended). Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended)
2 secondary outcomes
Survival status
Time frame: Up to 2 years
RECIST 1.1 response
Time frame: UP to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Related trials for Pancreatic Ductal Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
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.
Christos Fountilas, MD principal investigator
Roswell Park Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Roswell Park Cancer Institute at 2 sites in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christos Fountzilas, MD (716-845-2300, Christos.Fountzilas@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective prediction of pCR in resectable patients (time frame: Up to 2 years). 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 23 Jul 2026.