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

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ClinicalTrials.gov Identifier: NCT01692873
Recruitment Status : Recruiting
First Posted : September 25, 2012
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pancreatic Tumor Procedure: suspected pancreatic tumor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004
Study Start Date : February 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Biomarkers [ Time Frame: within twenty four hours ]
    Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers


Secondary Outcome Measures :
  1. Histology [ Time Frame: within twenty four hours ]
    To determine the histologic characteristics of the pancreatic tumor



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692873


Contacts
Contact: Dominique GENRE, MD 33 (0)4 91 22 37 78 bec@ipc.unicancer.fr
Contact: Agnès BOYER CHAMMARD, MD 33 (0)4 91 22 37 78 bec@ipc.unicancer.fr

Locations
France
Marine GILABERT, MD Recruiting
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Marine GILABERT, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01692873     History of Changes
Other Study ID Numbers: PACAomics / IPC 2011-004
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: August 2016

Keywords provided by Institut Paoli-Calmettes:
pancreatic tumor

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases