AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma
NCT ID: NCT06320717
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-01-02
2026-07-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients with Borderline Resectable (Cohort A)
Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy
Blood sample
To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients
Patients with Resectable (Cohort B)
Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy
Blood sample
To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients
Interventions
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Blood sample
To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Participant has a concurrent malignancy requiring active treatment during the study.
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Christos Fountilas, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center
Locations
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Good Samaritan University Hospital
West Islip, New York, United States
Countries
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Central Contacts
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Facility Contacts
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John Loscalzo, MD
Role: primary
Other Identifiers
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I-3574823
Identifier Type: -
Identifier Source: org_study_id
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