Clinical trial · Observational
Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds (VOC)
Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds Biomarkers in Bile and Serum in the Diagnosis of Malignant Biliary Strictures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-randomized natural history protocol in which patients undergoing surgery or endoscopy for suspected/ diagnosed pancreaticobiliary strictures are assigned to a) control (chronic pancreatitis, no pancreatic neoplasm, primary sclerosing cholangitis), b) non-carcinoma (bile duct stones, papillary stenosis, ), c) carcinoma non-pancreatic (ampullary and distal bile duct or cholangiocarcinoma) and d) pancreatic ductal adenocarcinoma (pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood and bile | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of biomarkers in the diagnosis of cancer
- timeFrame
- one year
- description
- Comparative efficacy of biomarkers, brush cytology, fluorescence in situ hybridization (FISH), carbohydrate antigen 19-9 (CA 19-9) and biliary and blood biomarkers (lipidomics, proteomics, micro RNAs and VOCs) in the diagnosis of malignancy.
Secondary outcomes (1)
- measure
- Medical Record Review
- timeFrame
- one year
- description
- Subjects who do not have a differential diagnosis of either cancer, biliary or pancreatic disease at the time of the index Endoscopic retrograde cholangiopancreatography (ERCP) will have their medical record reviewed quarterly for new diagnoses or procedures related to pancreatic malignancy, peri-ampullary malignancy, biliary disease, or pancreatic disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: Screening Criteria for Potential Participants in the Study 1. Age: ≥18years old 2. Treatment: scheduled for clinical reason to undergo an ERCP at the CIE 3. Suspected of having biliary or pancreatic disease other than cancer (chronic pancreatitis, benign biliary strictures, post-liver transplant strictures, common bile duct stones, sphincter of Oddi dysfunction or suspected of having pancreatic or peri-ampullary malignancy (including pancreatic ductal adenocarcinoma, distal cholangiocarcinoma, ampullary carcinoma, duodenal, carcinoma 4. Clinical or image data suggestive of pancreatic disease or the need for gastrointestinal or pancreatic inspection. 5. Willing and mentally able to provide consent Exclusion Criteria: 1. Age: \<18years old 2. Pregnant women 3. Post-bariatric surgery, hepaticojejunostomy and Bilroth II patients undergoing ERCP. 4. Not scheduled for endoscopic procedures for clinical reasons 5. No clinical or image data suggestive of need for clinical intervention (Endoscopy) 6. Not willing or able to sign informed consent..
References
Publications (1)
- DERIVEDNavaneethan U, Spencer C, Zhu X, Vargo JJ, Grove D, Dweik RA. Volatile organic compounds in bile can distinguish pancreatic cancer from chronic pancreatitis: a prospective observational study. Endoscopy. 2021 Jul;53(7):732-736. doi: 10.1055/a-1255-9169. Epub 2020 Sep 4. PMID 32894868