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

NCT02072616 | Terminated

• 1 other identifier: 2013/0141/HP
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Keywords

Circulating Tumor Cells; pancreatic adenocarcinoma; circulating tumor DNA (KRAS); CA 19.9

Outcome Measures

Primary Outcomes (1)

• sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma

  Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)

  Day 1

Secondary Outcomes (4)

• diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma

  Day 1

• prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9

  Day 1

• Time to first recurrence or death

  Month 36

• Time to first recurrence or death

  Month 18

Study Arms (1)

Sample for Circulating Tumoral Cells

EXPERIMENTAL

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

Other: Pancreatic adenocarcinoma diagnosis

Interventions

Pancreatic adenocarcinoma diagnosis OTHER

Sample for Circulating Tumoral Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David SEFRIOUI, MD

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: September 16, 2014
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1)