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

Study Locations

    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

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:
  • ChiRhoStim
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:
  • ChiRhoStim
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:
  • ChiRhoStim

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.

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

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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