Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. (CTC-Pancreas)
Primary Purpose
Circulating Tumor Cells, Pancreatic Adenocarcinoma, Circulating Tumor DNA (KRAS)
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Pancreatic adenocarcinoma diagnosis
Sponsored by
About this trial
This is an interventional diagnostic trial for Circulating Tumor Cells focused on measuring Circulating Tumor Cells, pancreatic adenocarcinoma, circulating tumor DNA (KRAS), CA 19.9
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
Sites / Locations
- UH RouenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sample for Circulating Tumoral Cells
Arm Description
Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma
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
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 to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
Time to first recurrence or death
Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
Full Information
NCT ID
NCT02072616
First Posted
February 24, 2014
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02072616
Brief Title
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
Acronym
CTC-Pancreas
Official Title
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sample for Circulating Tumoral Cells
Arm Type
Experimental
Arm Description
Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis
Intervention Type
Other
Intervention Name(s)
Pancreatic adenocarcinoma diagnosis
Primary Outcome Measure Information:
Title
sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma
Description
Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma
Description
Sensitivity, specificity and diagnostic accuracy of the detection of circulating tumor DNA (KRAS mutation) for the diagnosis of pancreatic adenocarcinoma.
Time Frame
Day 1
Title
prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9
Description
Sensitivity, specificity and diagnostic accuracy of the combined detection of CTCs and circulating tumor DNA (KRAS mutation) for the diagnosis of pancreatic adenocarcinoma
Time Frame
Day 1
Title
Time to first recurrence or death
Description
Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
Time Frame
Month 36
Title
Time to first recurrence or death
Description
Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
Time Frame
Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David SEFRIOUI, MD
Phone
+3323288
Ext
8610
Email
david.sefrioui@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT, M.
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David SEFRIOUI, MD
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David SEFRIOUI, MD
Phone
+3323288
Ext
8610
Email
david.sefrioui@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
David SEFRIOUI, MD
12. IPD Sharing Statement
Learn more about this trial
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
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