Prospective Registry of Patients With Pancreas Adenocarcinoma Resectable and Borderline (PaNLoCat)

PROSPECTIVE REGISTRY OF PATIENTS WITH BORDERLINE AND RESECTABLE PANCREATIC ADENOCARCINOMA IN CATALONIA (PaNLoCat)

Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival.

Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Effect; Pancreas Cancer
• Intervention / Treatment: Procedure: Neoadyuvant therapy

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient who has been diagnosed of ADK resectable or borderline and assessed in a multidiscliplinary tumor board between 2017 and 2021

Description

Inclusion Criteria:

• resectable or borderline pancreas ADK
• with or without radiotherapy
• any type of approach
• any type of surgery

Exclusion Criteria:

• locally advanced ADK
• No consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadyuvant therapy; Patients with borderline or resectable ADK subjected to neoadyuvant therapy	Procedure: Neoadyuvant therapy; Patients of group neoadyuvant therapy will receive any chemotherapy treatment before surgery
Upfront surgery; Patients with borderline or resectable ADK who undergo upfront surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	Three years follow-up

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenocarcinoma; Pancreatic Neoplasms
• Other Study ID Numbers: PaNLoCat_v4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No