Optical and Biochemical Biomarkers in Early Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT03404661
• Recruitment Status: Recruiting
• First Posted: January 19, 2018
• Last Update Posted: May 27, 2022
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Massimo Raimondo, M.D., Mayo Clinic

Study Description

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.

Study Design

• 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: April 2023
• Estimated Study Completion Date: April 2023

Groups and Cohorts

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

Outcome Measures

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).

Biospecimen Retention:   Samples With DNA

20cc of venous blood In case of pancreatic cyst, excess fluid above 2cc Excess tumor tissue including portions of cancer and normal tissue

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Karen Adams; 904-953-3511; adams.karen1@mayo.edu

Locations

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

• Principal Investigator: Massimo Raimondo, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Massimo Raimondo, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03404661
• Other Study ID Numbers: 17-005211
• First Posted: January 19, 2018
• Last Update Posted: May 27, 2022
• Last Verified: May 2022

• 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:

Secretin; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs