PAncreas Borderline and Locally Advanced Snapshot Study

Not yet recruiting

• Conditions: Pancreatic Cancer

• Registration Number: NCT05470738
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.)

Detailed 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".

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22
• Study Start: 2022-09-15
• Primary Completion: 2023-09-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 230

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	during 1 year	Evaluation of the rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively)

Secondary Outcome Measures

Name	Time	Method
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.	during 1 year	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)

Trial Locations

Locations (23)

CHU Bordeaux; 🇫🇷 Bordeaux, France

APHP Hopital de la Pitié-Salpétrière; 🇫🇷 Paris, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Nancy; 🇫🇷 Nancy, France

CHU Nantes; 🇫🇷 Nantes, France

APHM; 🇫🇷 Marseille, France

CHU Reims; 🇫🇷 Reims, France

APHP Hopital Beaujon; 🇫🇷 Paris, France

CHU Amiens; 🇫🇷 Amiens, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Nice; 🇫🇷 Nice, France

APHP Hopital Cochin; 🇫🇷 Paris, France

APHP Hopital Paul Brousse; 🇫🇷 Paris, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Tours; 🇫🇷 Tours, France

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Lille; 🇫🇷 Lille, France

Institut Paoli-Calmettes d'Unicancer; 🇫🇷 Marseille, France

CHU Montpellier; 🇫🇷 Montpellier, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France