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2017-02-15
2017-11-13
2017-11-13
52
NCT03032913
University Hospital, Bordeaux
University Hospital, Bordeaux
OBSERVATIONAL
Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - 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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-12-23 | N/A | 2018-04-09 |
2017-01-24 | N/A | 2018-04-10 |
2017-01-26 | N/A | 2018-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant 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
PROCEDURE: Portal vein blood sample
|
| : Non-cancer patients Patients with no Cancer | PROCEDURE: Blood samples
|
| Primary Outcome Measures | Measure Description | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
