Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. (CTC-Pancreas)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT02072616
First received: February 24, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Circulating Tumor Cells
Pancreatic Adenocarcinoma
Circulating Tumor DNA (KRAS)
CA 19.9
Other: Pancreatic adenocarcinoma diagnosis
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)


Secondary Outcome Measures:
  • diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9


Estimated Enrollment: 142
Study Start Date: March 2014
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sample for Circulating Tumoral Cells
Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis
Other: Pancreatic adenocarcinoma diagnosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072616

Contacts
Contact: David SEFRIOUI, MD +3323288 ext 8610 david.sefrioui@chu-rouen.fr
Contact: Julien BLOT, M. +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
France
UH Rouen Not yet recruiting
Rouen, France, 76031
Contact: David SEFRIOUI, MD    +3323288 ext 8610    david.sefrioui@chu-rouen.fr   
Contact: julien BLOT    +3323288 ext 8265    julien.blot@chu-rouen.fr   
Principal Investigator: david SEFRIOUI, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: David SEFRIOUI, MD UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02072616     History of Changes
Other Study ID Numbers: 2013/141/HP
Study First Received: February 24, 2014
Last Updated: February 24, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Rouen:
Circulating Tumor Cells
pancreatic adenocarcinoma
circulating tumor DNA (KRAS)
CA 19.9

Additional relevant MeSH terms:
Adenocarcinoma
Neoplastic Cells, Circulating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014