PAncreas Borderline and Locally Advanced Snapshot Study

NCT ID: NCT05470738

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-15

Study Completion Date

2024-09-15

Brief Summary

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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

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* 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".

Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Gagniere

Role: STUDY_DIRECTOR

University Hospital, Clermont-Ferrand

Locations

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CHU Amiens

Amiens, , France

Site Status

CHU Besançon

Besançon, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status

CHU Dijon

Dijon, , France

Site Status

CHU Lille

Lille, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

APHM

Marseille, , France

Site Status

Institut Paoli-Calmettes d'Unicancer

Marseille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU Nancy

Nancy, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Nice

Nice, , France

Site Status

APHP Hopital Beaujon

Paris, , France

Site Status

APHP Hopital Cochin

Paris, , France

Site Status

APHP Hopital de la Pitié-Salpétrière

Paris, , France

Site Status

APHP Hopital Paul Brousse

Paris, , France

Site Status

CHU Reims

Reims, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Other Identifiers

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2022 GAGNIERE PALASS

Identifier Type: -

Identifier Source: org_study_id

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