Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors (PACAomics)

August 10, 2018 updated by: Institut Paoli-Calmettes

Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004

Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.

Most patients present at diagnosis a non resectable, locally advanced or metastatic disease, with a median survival of 12 month.

The aim of this study is the identification of diagnosis biomarkers, predictive of the therapeutic response.

This project investigate the use of molecular analyses applied to pancreatic tumor cells collected by microbiopsy under ultrasound-endoscopy, and blood cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Marine GILABERT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspicion of pancreatic adenocarcinoma
  • Patient > 18 years old
  • Social Security affiliation
  • Signed informed consent

Exclusion Criteria:

  • Patient in emergency situation
  • Major person being the object of a legal protective measure or unable to express its consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: suspected pancreatic tumor
Realization of pancreatic tumor biopsy and blood samples
Procedure: suspected pancreatic tumor
Realization of pancreatic surgery to obtain tumor biopsy and blood samples to realize biomarkers analyses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers
Time Frame: within twenty four hours
Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers
within twenty four hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histology
Time Frame: within twenty four hours
To determine the histologic characteristics of the pancreatic tumor
within twenty four hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Marine GILABERT, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACAomics / IPC 2011-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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