Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

NCT ID: NCT05248750

Last Updated: 2024-02-13

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-22

Study Completion Date

2026-07-10

Brief Summary

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Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.

Detailed Description

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Conditions

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Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
* Availability of biopsies obtained during EUS-FNB
* Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
* Patients must be fit for chemotherapy administration
* They have to express their willingness to be followed up at our pancreatic high volume centers
* Age \>18 and \<80 years
* Able to sign informed consent

Exclusion Criteria

* Histological diagnoses other than pancreatic ductal adenocarcinoma
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Guido Costamagna

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Larghi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Locations

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"Agostino Gemelli" Hospital, Catholic University of Sacred Heart

Rome, Lazio, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alberto Larghi, MD

Role: CONTACT

+390630156580

Carolina Gualtieri

Role: CONTACT

+390630156580

Facility Contacts

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Guido Costamagna, MD, Prof.

Role: primary

+39.0630156580

MD

Role: backup

Other Identifiers

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PDAC AIRC

Identifier Type: -

Identifier Source: org_study_id

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