Prospective Registry of Patients With Pancreas Adenocarcinoma Resectable and Borderline

NCT05514171 | Completed

• 1 other identifier: PaNLoCat_v4
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy Effect; Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Three years follow-up

Study Arms (2)

Neoadyuvant therapy

Patients with borderline or resectable ADK subjected to neoadyuvant therapy

Procedure: Neoadyuvant therapy

Upfront surgery

Patients with borderline or resectable ADK who undergo upfront surgery

Interventions

Neoadyuvant therapy PROCEDURE

Patients of group neoadyuvant therapy will receive any chemotherapy treatment before surgery

Neoadyuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• locally advanced ADK
• No consent

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Spain

Location

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 24, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

ES (1)