Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC (PANC-CTC)

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Intervention / Treatment: Procedure: Blood samples; Procedure: Portal vein blood sample

Detailed Description

Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is currently available for this deadly disease, with an overall survival <5%. Survival can reach 20% when surgery is possible, giving the best chance to the patients. If patients present locally advance disease, it is crucial to quickly establish resectability to avoid unneeded and even deleterious surgery in patients with metastatic stages. It is also important to increase the rate of true R0 resection with effective preoperative therapy. However, when the cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory histologic proof is difficult to make with non-informative biopsies. It is necessary to find new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery when anatomo-pathologic proof is not available. New developments in the field of liquid biopsy hold great promise in providing valuable information for diagnosis assistance. The project will be run in two steps. First, several methods will be compared for tumor cell recovery after cell spiking in blood of non-cancer patients and pancreatic cell line onco-exosomes will characterized by flow cytometry. Second the best method will be used to detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+ exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established and compared. Correlations between circulating tumor elements presence and clinical and biological parameters will be evaluated at the time of the diagnosis. Patient clinical outcome will be assessed according to initial circulating element quantification.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pancreatic ductal adenocarcinoma patients; Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC	Procedure: Blood samples; Blood samples for both group; Procedure: Portal vein blood sample; Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group
Non-cancer patients; Patients with no Cancer	Procedure: Blood samples; Blood samples for both group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step 1: reproducibility of CTC detection with the 3 methods	Estimation with bilateral confidence interval of 95%. A mixed affect linear regression will be operated to obtain this estimation.	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Etienne BUSCAIL, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2017
• Primary Completion (ACTUAL): November 13, 2017
• Study Completion (ACTUAL): November 13, 2017

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; Adenocarcinoma; Pancreas; Pancreatic; Exosome; Circulating tumor cell (CTC); Ductal
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Neoplasm Metastasis; Adenocarcinoma; Neoplastic Cells, Circulating
• Other Study ID Numbers: CHUBX 2015/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No