Clinical trial NCT02818907: Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable
Official title: Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Cancéropôle Grand-Est
First posted: 2016-06-30
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.


Eligibility criteria: Inclusion Criteria:

* Patients with exocrine resectable pancreatic adenocarcinoma or potentially resectable (that after neoadjuvant treatment are considered appropriate candidates for resection)
* Histologically or cytologically documented diagnosis of exocrine pancreatic adenocarcinoma
* Written informed consent obtained prior enrollment in the study

Exclusion Criteria:

* other types of pancreatic cancer, in particular endocrine tumor or acinar cells
* ampulloma
* metastatic disease
* other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
* patient under guardianship, curator or under the protection of justice.

Primary outcomes:
measure: disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
timeFrame: date of first disease apparition [within 3 years after the enrollment of the last patient]
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
city: Nancy
country: France
facility: Institut de cancérologie de Lorraine
city: Reims
country: France
facility: Centre Hospitalier Universitaire Robert Debré
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hautepierre
Study officials:
References: