Registry for Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT03001505
• Recruitment Status: Withdrawn
• First Posted: December 23, 2016
• Last Update Posted: December 6, 2017
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: December 15, 2016
• First Posted Date: December 23, 2016
• Last Update Posted Date: December 6, 2017
• Actual Study Start Date: May 4, 2017
• Estimated Primary Completion Date: April 2037 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2017)

Overall survival [ Time Frame: 10 years ]

Survival from Diagnosis to time of death

• Original Primary Outcome Measures (submitted: December 20, 2016): Overall survival [ Time Frame: 10 years ]

Current Secondary Outcome Measures (submitted: March 27, 2017)

• Disease-free survival [ Time Frame: 10 years ]
  length of time with no evidence of disease
• Metastasis [ Time Frame: 10 years ]
  Radiographic or surgical evidence of disease spread beyond the pancreas (or resection bed if post surgery).
• Local recurrence [ Time Frame: 10 years ]
  Radiographic evidence of disease recurrence in the resection bed, if post surgery.

Original Secondary Outcome Measures (submitted: December 20, 2016)

• Disease-free survival [ Time Frame: 10 years ]
• Metastasis [ Time Frame: 10 years ]
  Radiographic or surgical evidence of disease spread beyond the pancreas (or resection bed if post surgery).
• Local recurrence [ Time Frame: 10 years ]
  Radiographic evidence of disease recurrence in the resection bed, if post surgery.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry for Pancreatic Cancer
• Official Title: Registry to Evaluate Multi-modality Therapies for Pancreatic Cancer
• Brief Summary: This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: 10 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients diagnosed with pancreatic cancer who are treated at DUHS
• Condition: Pancreatic Cancer
• Intervention: Not Provided

Study Groups/Cohorts

Patients with pancreatic cancer

Patients diagnosed with pancreatic cancer evaluated at this institution.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 4, 2017): 0
• Original Estimated Enrollment (submitted: December 20, 2016): 750
• Estimated Study Completion Date: April 2037
• Estimated Primary Completion Date: April 2037 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Pancreatic cancer

Exclusion Criteria:

• Younger than 18 years of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03001505
• Other Study ID Numbers: Pro00075769
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Duke University
• Study Sponsor: Duke University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sabino Zani, MD; DUHS

• PRS Account: Duke University
• Verification Date: December 2017