PAncreas Borderline and Locally Advanced Snapshot Study (PALASS)

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05470738

2022 GAGNIERE PALASS

Details and patient eligibility

About

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.)

Full 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".

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)