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RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer (PaCaBioMarkeR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575363
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:

PDAC (Pancreatic ductal adenocarcinoma) represents 90% of pancreatic tumors. The prognosis of PDAC remains poor at this time. Its management is based on surgery for early stages, associated with neoadjuvant and adjuvant chemotherapy. However, around 80% of patients will relapse after surgery. There is a lack of efficient biological biomarkers of PDAC, especially for prognosis. To date, CA19-9 is commonly used despite its lack of sensitivity and specificity.

Ribosomal protein SA (RPSA) is a transmembrane receptor localized at the cell surface but also in the cytosolic and nuclear regions. RPSA interacts with many proteins in the extracellular matrix (ECM), including laminin-1 and elastin. RPSA in involved in different cellular functions such as cell adhesion, migration, proliferation and differentiation. The expression of RPSA is increased in many cancers including breast, lung, prostate, pancreatic, etc. It could represent a molecular biomarker of tumor invasion and metastatic abilities. Moreover, the concentration of RPSA could be measured in the serum of patients with PDAC. Recent data suggest that a modification of the RPSA concentration could be a prognostic biomarker of PDAC.


Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma (PDAC) Other: Blood sample Not Applicable

Detailed Description:
The aim of this study is to explore the potential implication of RPSA as prognostic biomarker of PDAC.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: RPSA as a Potential Prognostic Biomarker of PDAC
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: pancreatic adenocarcinoma patient
patient with pancreatic ductal adenocarcinoma
 Other: Blood sample
Blood sample


Outcome Measures
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Primary Outcome Measures :
  1. RPSA serum concentration [ Time Frame: Day 0 ]
    The RPSA serum concentration is assessed with commercially available RPSA ELISA assay (MyBioSource - MBS9137288).


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

inclusion criteria :

  • Patients treated at the Reims University Hospital for a resectable or potentially resectable pancreatic tumor, with or without neoadjuvant chemotherapy
  • Adults (aged more than 18 years old)
  • Patients who have signed the informed consent form

exclusion criteria :

  • Patients with a prior history of cancer (excluding basal cell carcinoma or in situ cervical cancer that received conventional cancer treatment).
  • Minors
  • Patients for whom PDAC is not the retained diagnosis
Contacts and Locations
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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): NCT04575363


Contacts
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Contact: Jean-Baptiste OUDART 03 10 73 62 87 ext 0033 joudart@chu-reims.fr

Locations
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France
Damien JOLLY
Reims, France
Contact: Jean-Baptiste OUDART    03 10 73 62 87    joudart@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT04575363    
Other Study ID Numbers: PA20113
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Pancreatic ductal adenocarcinoma
Ribosomal protein SA (RPSA)
prognosis biomarker
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms