Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

NCT ID: NCT02072616

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2021-09-30

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.

Conditions

Circulating Tumor Cells; Pancreatic Adenocarcinoma; Circulating Tumor DNA (KRAS); CA 19.9

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sample for Circulating Tumoral Cells

Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis

Group Type: EXPERIMENTAL

Pancreatic adenocarcinoma diagnosis

Intervention Type: OTHER

Interventions

Pancreatic adenocarcinoma diagnosis

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David SEFRIOUI, MD

Role: PRINCIPAL_INVESTIGATOR

UH Rouen

Locations

UH Rouen

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David SEFRIOUI, MD

Role: CONTACT

david.sefrioui@chu-rouen.fr

+3323288 ext. 8610

Julien BLOT, M.

Role: CONTACT

julien.blot@chu-rouen.fr

+3323288 ext. 8265

Facility Contacts

David SEFRIOUI, MD

Role: primary

david.sefrioui@chu-rouen.fr

+3323288 ext. 8610

Other Identifiers

2013/141/HP

Identifier Type: -

Identifier Source: org_study_id