An observational study in Cholangiocarcinoma, Cancer of the Head of the Pancreas, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by CHU de Reims · Observational
The differential diagnosis between benign and malignant bile duct strictures is a difficult and demanding task for clinicians. Clinical, biochemical, and radiological characteristics of malignant biliary strictures are non-specific and tissue diagnosis is difficult to obtain preoperatively. For this reason, there is a need for the development of new diagnostic modalities. Of particular interest is the quest of tumor markers secreted or shed in bile by tumor cells developing in the biliary tract.
In addition, patient's tumor molecular profile is the basis for selecting personalized therapy. Cholangiocarcinomas are characterized by a large genetic heterogeneity. The most frequent mutations are TP53, KRAS, BRAF, EGFR, MET, NRAS, PIK3CA, ERBB2, SMAD4, FBXW7, ARID1A, PBRM1, BAP1 et IDH1/2. In the case of pancreatic cancers, the most frequent are KRAS mutation detected in 90 % of the patients and CDKN2A, SMAD4, TGFBR1, TGFBR2, ATM, BRCA2, MLL2, MLL3, KDM6A, ARID1A, ARID1B, SMARC1, GNAS and RNF43 mutations.
It is well established that KRAS and P53 mutations can be detected in bile samples from patients with biliary strictures related to cholangiocarcinoma and cancer of the head of the pancreas. The main objective is to determine if bile sample analysis from patients with malignant biliary stricture may allow to identify tumor mutation profile and determine tumor genotype. A secondary objective is to evaluate the diagnostic value of Vascular Endothelial Growth Factor (VEGF) and metallo-proteinases (MMPs) levels in bile samples.
Tumor genotyping will be performed in bile samples (supernatant and cell pellet) and tumor tissues in a series of 10 patients surgically treated for malignant biliary stricture related to cholangiocarcinoma or cancer of the head of the pancreas. The biochemical markers, VEGF and MMPs, will be assessed in bile samples obtained during endoscopic retrograde cholangiopancreatography in 50 patients with malignant biliary stricture and 50 patients treated for benign biliary diseases.
930 studies on the registry are indexed under Cholangiocarcinoma; 292 are open to participants now.
This study's enrollment of 100 is below the median of 176 across 180 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →CHU de Reims is the lead sponsor of 275 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with malignant biliary stricture and 50 patients with benign biliary diseases
Tumor genotyping in bile samples:
Inclusion criteria :
Exclusion criteria :
- patient who did not accept the storage of bile and tissue in the tissue Bank of Reims university hospital
Inclusion criteria:
Biological: bile sample analysis · Biological: biochemical markers, VEGF and MMPs, in bile samples
Biological: biochemical markers, VEGF and MMPs, in bile samples
tumor mutation profile tumor genotype
Tumor genotyping
Time frame: Day 0
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.