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Trial record 13 of 1620 for:    Pancreatic Cancer | United States

Optical and Biochemical Biomarkers in Early Pancreatic Cancer

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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

Tracking Information
First Submitted Date January 12, 2018
First Posted Date January 19, 2018
Last Update Posted Date March 1, 2019
Actual Study Start Date January 11, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2018)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03404661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optical and Biochemical Biomarkers in Early Pancreatic Cancer
Official Title Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study
Brief Summary The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pancreatic Cancer
Intervention 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
Study Groups/Cohorts
  • Pancreas Cancer Subjects
    Patients with pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.
    Intervention: Drug: Synthetic Human Secretin
  • 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.
    Intervention: Drug: Synthetic Human Secretin
  • Familial Pancreatic Cancer Subjects
    Subjects who have a family history of pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.
    Intervention: Drug: Synthetic Human Secretin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 12, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pujan Kandel, M.D. 904-953-3206 Kandel.Pujan@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03404661
Other Study ID Numbers 17-005211
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Michael Wallace, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Michael B. Wallace, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2019