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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01692873
First received: September 14, 2012
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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 Intervention
Pancreatic Tumor
Procedure: suspected pancreatic tumor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Biomarkers [ Time Frame: within twenty four hours ] [ Designated as safety issue: No ]
    Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers


Secondary Outcome Measures:
  • Histology [ Time Frame: within twenty four hours ] [ Designated as safety issue: No ]
    To determine the histologic characteristics of the pancreatic tumor


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01692873     History of Changes
Other Study ID Numbers: PACAomics / IPC 2011-004
Study First Received: September 14, 2012
Last Updated: September 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
pancreatic tumor

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

ClinicalTrials.gov processed this record on September 18, 2014