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Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases

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: NCT02471170
Recruitment Status : Suspended (on hold due to COVID-19)
First Posted : June 15, 2015
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
The purpose of this study is to collect blood samples to detect potential markers of pancreatic cancer in the blood and link these findings to medical and health information. Information from this study may help to provide insight into the detection of pancreas cancer in the blood before it can be found by other methods or provide a method of monitoring the status of pancreatic cancer throughout a treatment course. Another purpose of this study is to collect blood to create a biobank.

Condition or disease
Pancreatic Diseases

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Actual Study Start Date : September 10, 2015
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Collection of blood and tissue samples from subjects with pancreatic diseases [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
The frequency of research blood collection will not exceed 60 mL in a 1 week period and will not occur more frequently than 4 times in an 8 week period.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with pancreatic diseases
Criteria

Inclusion Criteria:

  1. The subject must be a patient at the Hospital of the University of Pennsylvania

    • The subject must be under evaluation and/or treatment for a pancreatic disease
    • The subject must be under evaluation and/or treatment for a non-pancreatic disease. For example, patients undergoing routine colonoscopy within the clinical practice will be asked to consent to provide control samples.
  2. The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf
  3. The subject must be 18 years of age or older

Exclusion Criteria:

  1. The subject or acceptable surrogate does not provide informed consent
  2. Subject is a prisoner
  3. Subject is under 18 years of age

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): NCT02471170


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Peter O'Dwyer, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02471170    
Other Study ID Numbers: UPCC 02215
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases