PAncreas Borderline and Locally Advanced Snapshot Study

Pancreatic Cancer Clinical Trial

— PALASS  

Official title:

PAncreas Borderline and Locally Advanced Snapshot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05470738
• Other study ID #: 2022 GAGNIERE PALASS
• Status: Not yet recruiting
• Start date: September 15, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: July 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The project's objective is to carry out prospectively, in France, for one year, a descriptive registry study in the management of patients with borderline or locally advanced pancreatic adenocarcinoma, and to collect both the patient's demographic characteristics, but also the therapeutic regimens applied, the types of surgeries performed and the outcome of the patients after surgery, and at three months of follow up (preoperative data, complications's post surgery, quality of the resection, etc.)

Description:

• Multicenter, observational prospective study over one year in France in patients with borderline or locally advanced pancreatic adenocarcinoma operated between September 2022 and August 2023.

• Patients will be screened by the pancreatic's surgeons practicing in a reference centers during preoperative surgical consultations (V1),

• The patient's non-objection will be sollected,

• The end of follow-up's patient will take place during the post-operative consultation approximately 3 months after surgery (V3)

• Between V1 and V3, preoperative data (demography, history, tumor characteristics, neoadjuvant treatments performed, tumor response), operative, intraoperative, pathological and postoperative data will be collected via a e-CRF " the REDCAP software".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient over the age of 18, operated on for pancreatic adenocarcinoma, borderline or locally advanced, between September 2022 and August 2023, in France

• Diagnosis of pancreatic adenocarcinoma:

• either after cytopuncture with anatomopathological result confirming the diagnosis,

• or with strong suspicion on the combined criterias : clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations ) in the event of absence of anatomopathological documentation (failure of several fine needle punctures (maximum 3)/or non-contributory anatomopathological examinations),

• Borderline or locally advanced character depending on the presence of a contact of the tumor with nearby vessels and defined by morphological examination (scanner +/- MRI). These criteria are defined by the NCCN Guidelines for Pancreatic Adenocarcinoma V.1.2021, international reference

Exclusion Criteria:

• Patient under juridic protected or subject to any measure of legal protection,

• Patients not operated on for their pancreatic adenocarcinoma,

• Adenocarcinoma of the pancreas operable immediately on diagnosis,

• Metastatic pancreatic adenocarcinoma from the outset on diagnosis,

• Patient without pancreatic adenocarcinoma after histological examination (in the case where the pancreatic lesion was operated on for strong suspicion of pancreatic adenocarcinoma on the combined clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations, but that the lesion on definitive pathological examination is not a pancreatic adenocarcinoma)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CHU clermont-ferrand	Clermont-Ferrand
France	CHU Dijon	Dijon
France	CHU Lille	Lille
France	Hospices Civils de Lyon	Lyon
France	APHM	Marseille
France	Institut Paoli-Calmettes d'Unicancer	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	CHU Nice	Nice
France	APHP Hopital Beaujon	Paris
France	APHP Hopital Cochin	Paris
France	APHP Hopital de la Pitié-Salpétrière	Paris
France	APHP Hopital Paul Brousse	Paris
France	CHU Reims	Reims
France	CHU Rennes	Rennes
France	CHU Rouen	Rouen
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main study's objective is to definite the effective rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively), which is essential marker recognized as improving overall survival.	Evaluation of the rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively)	during 1 year
Secondary	The secondary objective of the study is to know, in patients operated for pancreatic adenocarcinoma, the rate of postoperative complications, the rate of the postoperative morbidity and mortality, and the quality of the resection.	the secondary objective will be definited by evaluation of the rate of postoperative complications, the rate of postoperative morbidity and mortality and the quality of the resection (R0)	during 1 year