- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743049
Collection of Circulating Biomarkers in Pancreatic Cancer
April 2, 2026 updated by: Abramson Cancer Center at Penn Medicine
Protocol to Permit Collection of Circulating Biomarkers in Pancreatic Cancer
This protocol will involve collection of blood samples from patients with a diagnosis of pancreatic adenocarcinoma for evaluation of circulating biomarkers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mark O'Hara, MD
- Phone Number: 215-360-0919
- Email: Mark.OHara@pennmedicine.upenn.edu
Study Contact Backup
- Name: Liudmila Mazaleuskaya, PhD
- Phone Number: 267-455-9141
- Email: mazali@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Abramson Cancer Center at University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
known or suspected diagnosis of pancreatic adenocarcinoma
Description
Inclusion Criteria:
- The subject must have a known or presumed diagnosis of pancreatic adenocarcinoma
- The subject must be a patient of the University of Pennsylvania
- The subject must be able to provide informed consent
- The subject must be 18 years of age or older
Exclusion Criteria:
. Subjects who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent are ineligible to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Blood specimens
Collection of blood for analysis of various circulating biomarkers in patients with pancreatic adenocarcinoma.
|
4 tbsp of blood in a 1-week period, occurring no more frequently than 4 times in an 8-week period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To create a comprehensive system to collect, catalogue and store blood specimens from subjects with pancreatic cancer for future research use.
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To create a computerized clinical data set from subjects with pancreatic cancer that contains information related to the subject's general health, disease status, treatments, and response.
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
To integrate the data and specimens to permit the most informative clinical-biologic research platform.
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark O'Hara, MD, Abramson Cancer Center, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
January 15, 2028
Study Registration Dates
First Submitted
February 10, 2023
First Submitted That Met QC Criteria
February 22, 2023
First Posted (Actual)
February 24, 2023
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 20222
- 852628 (Other Identifier: University of Pennsylvania IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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