Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds (VOC)

NCT02531607 | Active Not Recruiting

• 1 other identifier: 649074
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of biomarkers in the diagnosis of cancer

  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.

  one year

Secondary Outcomes (1)

• Medical Record Review

  one year

Interventions

blood and bile OTHER

20ml of blood will be obtained from consented participants. 5ml of bile will be collected during the endoscopic procedure.

Eligibility Criteria

• Age: 19 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for ERCP at the Center for Interventional Endoscopy (CIE)

You may qualify if:

• Screening Criteria for Potential Participants in the Study
• Age: ≥18years old
• Treatment: scheduled for clinical reason to undergo an ERCP at the CIE
• 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
• Clinical or image data suggestive of pancreatic disease or the need for gastrointestinal or pancreatic inspection.
• Willing and mentally able to provide consent

You may not qualify if:

• Age: \<18years old
• Pregnant women
• Post-bariatric surgery, hepaticojejunostomy and Bilroth II patients undergoing ERCP.
• Not scheduled for endoscopic procedures for clinical reasons
• No clinical or image data suggestive of need for clinical intervention (Endoscopy)
• Not willing or able to sign informed consent..

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth

Orlando, Florida, 32803, United States

Location

Related Publications (1)

• Navaneethan 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

bile and blood

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard Pratley, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: August 24, 2015
• Study Start: November 13, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)