Clinical trial NCT05470738: PAncreas Borderline and Locally Advanced Snapshot Study
Official title: PAncreas Borderline and Locally Advanced Snapshot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
adenocarcinoma
locally advanced cancer
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient operated on for pancreatic adenocarcinoma, borderline or locally advanced, between September 2022 and August 2023, in France

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".

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: during 1 year
Secondary outcomes:
measure: 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.
timeFrame: during 1 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: APHM
city: Marseille
country: France
facility: Institut Paoli-Calmettes d'Unicancer
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: APHP Hopital Beaujon
city: Paris
country: France
facility: APHP Hopital Cochin
city: Paris
country: France
facility: APHP Hopital de la Pitié-Salpétrière
city: Paris
country: France
facility: APHP Hopital Paul Brousse
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Johan Gagniere
role: STUDY_DIRECTOR
References: