Informations générales (source: ClinicalTrials.gov)
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. (CTC-Pancreas)
Interventional
Phase 3
University Hospital, Rouen (Voir sur ClinicalTrials)
septembre 2014
septembre 2021
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| UH Rouen - 76031 - Rouen - France | David SEFRIOUI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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