Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. (CTC-Pancreas)
Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.
|Circulating Tumor Cells Pancreatic Adenocarcinoma Circulating Tumor DNA (KRAS) CA 19.9||Other: Pancreatic adenocarcinoma diagnosis||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.|
- sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma [ Time Frame: Day 1 ]Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)
- diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma [ Time Frame: Day 1 ]Sensitivity, specificity and diagnostic accuracy of the detection of circulating tumor DNA (KRAS mutation) for the diagnosis of pancreatic adenocarcinoma.
- prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9 [ Time Frame: Day 1 ]Sensitivity, specificity and diagnostic accuracy of the combined detection of CTCs and circulating tumor DNA (KRAS mutation) for the diagnosis of pancreatic adenocarcinoma
- Time to first recurrence or death [ Time Frame: Month 36 ]Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
- Time to first recurrence or death [ Time Frame: Month 18 ]Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||September 2021|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: Sample for Circulating Tumoral Cells
Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis
|Other: Pancreatic adenocarcinoma diagnosis|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02072616
|Contact: David SEFRIOUI, MD||+3323288 ext firstname.lastname@example.org|
|Contact: Julien BLOT, M.||+3323288 ext email@example.com|
|Rouen, France, 76031|
|Contact: David SEFRIOUI, MD +3323288 ext 8610 firstname.lastname@example.org|
|Principal Investigator: David SEFRIOUI, MD|
|Principal Investigator:||David SEFRIOUI, MD||UH Rouen|