Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optical and Biochemical Biomarkers in Early Pancreatic Cancer

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.
 
ClinicalTrials.gov Identifier: NCT03404661
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic

Brief Summary:
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.

Condition or disease Intervention/treatment
Pancreatic Cancer Drug: Synthetic Human Secretin

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pancreas Cancer Subjects
Patients with pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.
Drug: Synthetic Human Secretin
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
Other Name: 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.
Drug: Synthetic Human Secretin
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
Other Name: ChiRhoStim

Familial Pancreatic Cancer Subjects
Subjects who have a family history of pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.
Drug: Synthetic Human Secretin
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
Other Name: ChiRhoStim




Primary Outcome Measures :
  1. 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).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03404661


Contacts
Layout table for location contacts
Contact: Pujan Kandel, M.D. 904-953-3206 Kandel.Pujan@mayo.edu

Locations
Layout table for location information
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kandel Pujan, M.D.    904-953-3206    Kandel.Pujan@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Michael B. Wallace, M.D. Mayo Clinic

Layout table for additonal information
Responsible Party: Michael Wallace, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03404661     History of Changes
Other Study ID Numbers: 17-005211
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs