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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02531607
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Pancreatic Neoplasms Other: blood and bile

Detailed Description:

Visit 1 for all participants will consist of going over the Informed Consent form and talking with the patient about the study. If the patient agrees to participate, he/she will be asked to sign the form, and a copy will be given to him/her for his/her records. This will be conducted during the day of the endoscopic procedure before the participant is under anesthesia.

Consented participants will have 20ml of blood collected via venipuncture of peripheral vein drawn by the endoscopy unit staff during their endoscopy procedure. The blood will be collected into heparinized vacutainers and immediately labeled with study specific code identifier and placed at 4⁰C until processed (within 24hr).

For clinical purposes, tissue may be removed during the endoscopic procedures. This tissue will be given to the Diagnostic Pathology (DP) personnel associated with the case for analysis. The diagnostic sample will be processed for DP use and stored in the DP active archives. No additional tissue will be taken solely for the purposes of this research study. However, if DP approves the use of the remaining clinical diagnostic, small cores or slides will be taken after the diagnostic use from the approved paraffin-embedded tissue blocks for use in comparison/confirmatory analyses to the bile and blood analyses done for this research project.

During the endoscopic procedures a 5ml aspiration of bile fluid will be collected for this study with the endoscopic instrument. The fluid will be transferred to a sterile tube, sealed, and placed at 4⁰C until processed (within 24hr). Both blood and fluids samples will be transferred to Translational Research Institute (TRI) R&D for analysis.

Follow Up (follow up will take place for all groups listed on page 7 of the protocol under "Study Design" with the exception of group B) 2 weeks post procedure- A member of the research staff will call the participant to assess for any complications Periodic medical record auditing for outcome data will be collected every three months for up to 1 year after enrollment.

One year post procedure- A member of the research staff will call the participant to assess for any complications

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds Biomarkers in Bile and Serum in the Diagnosis of Malignant Biliary Strictures
Study Start Date : June 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: blood and bile
    20ml of blood will be obtained from consented participants. 5ml of bile will be collected during the endoscopic procedure.

Primary Outcome Measures :
  1. Sensitivity and specificity of biomarkers in the diagnosis of cancer [ Time Frame: one year ]
    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 Outcome Measures :
  1. Medical Record Review [ Time Frame: one year ]
    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.

Biospecimen Retention:   Samples With DNA
bile and blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for ERCP at the Center for Interventional Endoscopy (CIE)

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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02531607

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Contact: Uday Navaneethan, MD 407-303-5503
Contact: Shyam Varadarajulu, MD 4073039736

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United States, Florida
Florida Hospital Center for Interventional Endoscopy Recruiting
Orlando, Florida, United States, 32803
Contact: Uday Navaneethan, MD    407-303-2879   
Contact: Shyam Varadarajulu, MD    407-303-9736   
Sponsors and Collaborators
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Principal Investigator: Uday Navaneethan, MD AdventHealth
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AdventHealth Identifier: NCT02531607    
Other Study ID Numbers: 649074
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases