Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable

Pancreatic Cancer Clinical Trial

— Pancreas-CGE  

Official title:

Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02818907
• Other study ID #: Pancreas-CGE
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2023

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Bruno HEYD, Pr
• Email: bruno.heyd[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Additional biological samples
blood and tumor tissue samples

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	Centre Georges François Leclerc	Dijon
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Centre Hospitalier Universitaire de Nancy	Nancy
France	Institut de cancérologie de Lorraine	Nancy
France	Centre Hospitalier Universitaire Robert Debré	Reims
France	Centre Paul Strauss	Strasbourg
France	CHU de Strasbourg - Hautepierre	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Cancéropôle Grand-Est

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)	DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials	date of first disease apparition [within 3 years after the enrollment of the last patient]