Pancreatic NeoplasmsNCT02531607
Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds (VOC)
An observational study of Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 95 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- blood and bile
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2014to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for ERCP at the Center for Interventional Endoscopy (CIE)
Who may be able to join
- 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
Who cannot join
- 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..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds Biomarkers in Bile and Serum in the Diagnosis of Malignant Biliary Strictures
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.
Read the 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
- Conditions
- Pancreatic Neoplasms
- Being tested
- blood and bile
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and bileOther
20ml of blood will be obtained from consented participants. 5ml of bile will be collected during the endoscopic procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Medical Record Review
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start13 Nov 2014
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Pratley, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531607
- Sponsor's protocol ID
- 649074
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2015
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32894868
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds Biomarkers in Bile and Serum in the Diagnosis of Malignant Biliary Strictures
- ClinicalTrials.gov ID
- NCT02531607
- Acronym / sponsor ID
- 649074
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 13 Nov 2014 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for ERCP at the Center for Interventional Endoscopy (CIE)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and bile20ml of blood will be obtained from consented participants. 5ml of bile will be collected during the endoscopic procedure. | Other | – |
Primary outcome
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.
1 secondary outcome
Medical Record Review
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 32894868Navaneethan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Pratley, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of biomarkers in the diagnosis of cancer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.