PAncreas Borderline and Locally Advanced Snapshot Study
PALASS
1 other identifier
observational
230
1 country
23
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2024
CompletedJuly 22, 2022
July 1, 2022
1 year
July 20, 2022
July 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Eligibility Criteria
Any patient operated on for pancreatic adenocarcinoma, borderline or locally advanced, between September 2022 and August 2023, in France
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
CHU Amiens
Amiens, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU clermont-ferrand
Clermont-Ferrand, 63000, 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, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johan Gagniere
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 22, 2022
Study Start
September 15, 2022
Primary Completion
September 15, 2023
Study Completion
September 15, 2024
Last Updated
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share