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

NCT ID: NCT02818907

Last Updated: 2024-09-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-19

Study Completion Date

2023-07-07

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Additional biological samples

Additional blood samples will be realized specifically to the study at baseline, after neoadjuvant chemotherapy (if applicable) and before surgery, 1 month after surgery and 1 month after the last adjuvant chemotherapy cycle.

Peripheral blood mononuclear cell (PBMC), plasma and circulating tumor DNA and RNA will be collected.

Tumor tissue will be collected during surgery.

Group Type OTHER

Additional biological samples

Intervention Type OTHER

blood and tumor tissue samples

Interventions

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Additional biological samples

blood and tumor tissue samples

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancéropôle Grand-Est

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Régional Universitaire de Besançon

Besançon, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

Centre Hospitalier Universitaire de Dijon

Dijon, , France

Site Status

Centre Hospitalier Universitaire de Nancy

Nancy, , France

Site Status

Institut de cancérologie de Lorraine

Nancy, , France

Site Status

Centre Hospitalier Universitaire Robert Debré

Reims, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

CHU de Strasbourg - Hautepierre

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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Pancreas-CGE

Identifier Type: -

Identifier Source: org_study_id

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