RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer (PaCaBioMarkeR)
Primary Purpose
Pancreatic Ductal Adenocarcinoma (PDAC)
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by

About this trial
This is an interventional diagnostic trial for Pancreatic Ductal Adenocarcinoma (PDAC) focused on measuring Pancreatic ductal adenocarcinoma, Ribosomal protein SA (RPSA), prognosis biomarker
Eligibility 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
Sites / Locations
- Damien JOLLY
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pancreatic adenocarcinoma patient
Arm Description
patient with pancreatic ductal adenocarcinoma
Outcomes
Primary Outcome Measures
RPSA serum concentration
The RPSA serum concentration is assessed with commercially available RPSA ELISA assay (MyBioSource - MBS9137288).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04575363
Brief Title
RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer
Acronym
PaCaBioMarkeR
Official Title
RPSA as a Potential Prognostic Biomarker of PDAC
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The aim of this study is to explore the potential implication of RPSA as prognostic biomarker of PDAC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma (PDAC)
Keywords
Pancreatic ductal adenocarcinoma, Ribosomal protein SA (RPSA), prognosis biomarker
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pancreatic adenocarcinoma patient
Arm Type
Experimental
Arm Description
patient with pancreatic ductal adenocarcinoma
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood sample
Primary Outcome Measure Information:
Title
RPSA serum concentration
Description
The RPSA serum concentration is assessed with commercially available RPSA ELISA assay (MyBioSource - MBS9137288).
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Baptiste OUDART
Phone
03 10 73 62 87
Ext
0033
Email
joudart@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste OUDART
Phone
03 10 73 62 87
Email
joudart@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer
We'll reach out to this number within 24 hrs