Clinical trial NCT03032913: Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
Official title: Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Keywords: Pancreas
Pancreatic
Cancer
Circulating tumor cell (CTC)
Adenocarcinoma
Ductal
Exosome
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with no cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments
timeFrame: 6 months
measure: Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.
timeFrame: 18 months
Secondary outcomes:
measure: Step 1: reproducibility of CTC detection with the 3 methods
timeFrame: 6 months
measure: Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome
timeFrame: 18 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Etienne BUSCAIL
role: PRINCIPAL_INVESTIGATOR
References: