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Registry for 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03001505
Recruitment Status : Withdrawn (Study design changed to clinical database only with no research question to be studied.)
First Posted : December 23, 2016
Last Update Posted : December 6, 2017
Sponsor:
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 ]
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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