- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404661
Optical and Biochemical Biomarkers in Early Pancreatic Cancer
June 5, 2023 updated by: Massimo Raimondo, M.D., Mayo Clinic
Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum.
From within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor.
Once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning.
This entire process from secretin injection to sample collection takes an average of 5 minutes.
The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed.
The top 10 candidate markers from discovery and validation on tissue (AUCs >0.95) and from pilot pancreatic-juice testing (AUCs >0.9) will be evaluated in this study.
Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite treated using optimized methods.
Then, an assay of aberrant methylation on target genes will be conducted using the QuARTS technique.
Results will be normalized to either a human DNA marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic epithelium.
Study Type
Observational
Enrollment (Actual)
346
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen Adams
- Phone Number: 904-953-3511
- Email: adams.karen1@mayo.edu
Study Locations
-
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with pancreas cancer, controls at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms, and subjects with a familial history of pancreas cancer.
Description
Inclusion Criteria:
- Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer.
- International normalized ratio (INR) less than 1.5
- Platelet count >50,000
Exclusion Criteria:
- Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding
- Pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pancreas Cancer Subjects
Patients with pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.
|
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
Other Names:
|
Control Subjects
Controls will receive Synthetic Human Secretin during an endoscopy procedure.
Controls are at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms.
|
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
Other Names:
|
Familial Pancreatic Cancer Subjects
Subjects who have a family history of pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.
|
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Methylated DNA markers as measured by mean percentage of total human DNA per pancreatic juice volume
Time Frame: one year
|
After pancreatic juice is collected, top 10 markers for pancreas cancer detection will be done from discovery and validation on tissue (AUC>.95) and from pilot pancreatic-juice testing (AUCs >0.9).
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Massimo Raimondo, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2018
Primary Completion (Actual)
March 10, 2022
Study Completion (Actual)
March 10, 2022
Study Registration Dates
First Submitted
January 12, 2018
First Submitted That Met QC Criteria
January 12, 2018
First Posted (Actual)
January 19, 2018
Study Record Updates
Last Update Posted (Actual)
June 6, 2023
Last Update Submitted That Met QC Criteria
June 5, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Secretin
Other Study ID Numbers
- 17-005211
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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