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

NCT05248750 | Recruiting

• 1 other identifier: PDAC AIRC
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Cancer

Keywords

pancreatic cancer; endoscopic ultrasound (EUS); personalized medicine

Outcome Measures

Primary Outcomes (2)

• Progression-free-survival (PFS)

  To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.

  From date of enrollment assessed until death or up to 2 years

• Overall survival

  To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.

  From date of enrollment assessed until death or up to 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB over a 3 year period. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, and metastatic.

You may qualify if:

• 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

You may not qualify if:

• Histological diagnoses other than pancreatic ductal adenocarcinoma
• Pregnancy or lactation

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

"Agostino Gemelli" Hospital, Catholic University of Sacred Heart

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alberto Larghi, MD

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Larghi, MD

CONTACT

+390630156580; alberto.larghi@yahoo.it

Carolina Gualtieri

CONTACT

+390630156580

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: July 22, 2021
• Primary Completion: July 10, 2024
• Study Completion (Estimated): July 10, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

IT (1)