Clinical trial NCT02072616: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
Official title: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Circulating Tumor Cells
Pancreatic Adenocarcinoma
Circulating Tumor DNA (KRAS)
CA 19.9
Keywords: Circulating Tumor Cells
pancreatic adenocarcinoma
circulating tumor DNA (KRAS)
CA 19.9
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female, and \> 18 years of age
* Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
* Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
* Patient has agree to participate by giving written informed consent

Exclusion Criteria:

* metastatic pancreatic tumor
* cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
* minor patient under 18 years
* contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
* patient under guardianship
* Pregnant or lactating women

Primary outcomes:
measure: sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma
timeFrame: Day 1
Secondary outcomes:
measure: diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma
timeFrame: Day 1
measure: prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9
timeFrame: Day 1
measure: Time to first recurrence or death
timeFrame: Month 36
measure: Time to first recurrence or death
timeFrame: Month 18
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH Rouen
Study officials:
affiliation: UH Rouen
name: David SEFRIOUI, MD
role: PRINCIPAL_INVESTIGATOR
References: