PaCaBioMarkeR: RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer

• Sponsor: CHU de Reims (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04575363
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Ductal Adenocarcinoma (PDAC)	Other: Blood sample	N/A

Detailed Description

The aim of this study is to explore the potential implication of RPSA as prognostic biomarker of PDAC.

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pancreatic adenocarcinoma patient patient with pancreatic ductal adenocarcinoma	Other: Blood sample; Blood sample

Outcome Measures

Primary Outcome Measures

1. RPSA serum concentration [Day 0]

   The RPSA serum concentration is assessed with commercially available RPSA ELISA assay (MyBioSource - MBS9137288).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Damien JOLLY	Reims		France

Sponsors and Collaborators

• CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT04575363
• Other Study ID Numbers: PA20113
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Jul 1, 2020

• 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: Adenocarcinoma

Study Results

No Results Posted as of Oct 5, 2020