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

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Interventions: Procedure: Blood samples; Procedure: Portal vein blood sample

• Registration Number: NCT03032913
• Lead Sponsor: University Hospital, Bordeaux

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.

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 Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Study Start: 2017-02-15
• Primary Completion: 2017-11-13
• Study Completion: 2017-11-13
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic ductal adenocarcinoma patients	Blood samples	Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC
Non-cancer patients	Blood samples	Patients with no Cancer
Pancreatic ductal adenocarcinoma patients	Portal vein blood sample	Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC

Primary Outcome Measures

Name	Time	Method
Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.	18 months
Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments	6 months

Secondary Outcome Measures

Name	Time	Method
Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome	18 months
Step 1: reproducibility of CTC detection with the 3 methods	6 months	Estimation with bilateral confidence interval of 95%. A mixed affect linear regression will be operated to obtain this estimation.

Trial Locations

Locations (1)

Chu de Bordeaux; 🇫🇷 Bordeaux, France