NCT04575363

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2021Oct 2027

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2027

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

September 29, 2020

Last Update Submit

November 8, 2023

Conditions

Keywords

Pancreatic ductal adenocarcinomaRibosomal protein SA (RPSA)prognosis biomarker

Outcome Measures

Primary Outcomes (1)

  • RPSA serum concentration

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

    Day 0

Study Arms (1)

pancreatic adenocarcinoma patient

EXPERIMENTAL

patient with pancreatic ductal adenocarcinoma

Other: Blood sample

Interventions

Blood sample

pancreatic adenocarcinoma patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Jean-Baptiste OUDART

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

October 18, 2021

Primary Completion (Estimated)

October 18, 2026

Study Completion (Estimated)

October 18, 2027

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations