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

Pancreatic Ductal Adenocarcinoma (PDAC) Clinical Trial

— PANC-CTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032913
• Other study ID #: CHUBX 2015/26
• Status: Completed
• First received: December 23, 2016
• Last updated: April 9, 2018
• Start date: February 15, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: April 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplastic Cells, Circulating
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Pancreatic Neoplasms

Intervention

Procedure:
• Blood samples
Blood samples for both group
• Portal vein blood sample
Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group

Locations

Country	Name	City	State
France	Chu de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments		6 months
Primary	Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.		18 months
Secondary	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
Secondary	Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome		18 months