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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248750
• Other study ID #: PDAC AIRC
• Status: Recruiting
• Start date: July 22, 2021
• Est. completion date: July 10, 2026

Study information

• Verified date: February 2024
• Source: Catholic University of the Sacred Heart
• Contact: Alberto Larghi, MD
• Phone: +390630156580
• Email: alberto.larghi[@]yahoo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 10, 2026
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Italy	"Agostino Gemelli" Hospital, Catholic University of Sacred Heart	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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