Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds (VOC)
|Study Design:||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|
- 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.
- 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
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Other: blood and bile
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02531607
|Contact: Uday Navaneethan, MD||407-303-5503||udayakumar.navaneethan.MD@flhosp.org|
|Contact: Shyam Varadarajulu, MDfirstname.lastname@example.org|
|United States, Florida|
|Florida Hospital Center for Interventional Endoscopy||Recruiting|
|Orlando, Florida, United States, 32803|
|Contact: Uday Navaneethan, MD 407-303-2879 uday.navaneethan.MD@flhosp.org|
|Contact: Shyam Varadarajulu, MD 407-303-9736 shyam.varadarajulu.MD@flhosp.org|
|Principal Investigator:||Uday Navaneethan, MD||Florida Hospital|