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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT03032913

Collaborator

(none)

Enrollment

Location

8.9

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Ductal Adenocarcinoma (PDAC)	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 Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 15, 2017

Actual Primary Completion Date :

Nov 13, 2017

Actual Study Completion Date :

Nov 13, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.
Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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