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Completed

NCT Number: NCT02818907

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Additional biological samples

Other

blood and tumor tissue samples

Primary outcomes

  1. disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)

    Time frame: date of first disease apparition [within 3 years after the enrollment of the last patient]

    DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Cancéropôle Grand-Est

Registry information

Official study title

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

Acronym: Pancreas-CGE

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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