NCT03032913

Brief Summary

The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2017

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

December 23, 2016

Last Update Submit

April 9, 2018

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

PancreasPancreaticCancerCirculating tumor cell (CTC)AdenocarcinomaDuctalExosome

Outcome Measures

Primary Outcomes (2)

  • Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments

    6 months

  • Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.

    18 months

Secondary Outcomes (2)

  • Step 1: reproducibility of CTC detection with the 3 methods

    6 months

  • Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome

    18 months

Study Arms (2)

Pancreatic ductal adenocarcinoma patients

Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC

Procedure: Blood samplesProcedure: Portal vein blood sample

Non-cancer patients

Patients with no Cancer

Procedure: Blood samples

Interventions

Blood samplesPROCEDURE

Blood samples for both group

Non-cancer patientsPancreatic ductal adenocarcinoma patients
Portal vein blood samplePROCEDURE

Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group

Pancreatic ductal adenocarcinoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with no cancer

You may qualify if:

  • Patient with informed consent
  • Patient with health care coverage
  • Group of PDAC patients: Patient with resectable lesion with suspicion or recent diagnosis of PDAC recruited in the surgery department
  • Group of non-cancer patients: Patients in the surgery department without cancer lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or sleeve gastrectomy procedure

You may not qualify if:

  • Patients \<18 or under tutelage
  • Patient with recent chemotherapy or radiotherapy
  • Pregnant or lactating woman
  • Patient with negative or non-informative biopsy
  • Patient with technically unserectable disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

NeoplasmsNeoplastic Cells, CirculatingAdenocarcinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Etienne BUSCAIL

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 26, 2017

Study Start

February 15, 2017

Primary Completion

November 13, 2017

Study Completion

November 13, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)