NCT05743049

Brief Summary

This protocol will involve collection of blood samples from patients with a diagnosis of pancreatic adenocarcinoma for evaluation of circulating biomarkers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2023Jan 2028

First Submitted

Initial submission to the registry

February 10, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

February 10, 2023

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To create a comprehensive system to collect, catalogue and store blood specimens from subjects with pancreatic cancer for future research use.

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • 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.

    Through study completion, an average of 1 year

  • To integrate the data and specimens to permit the most informative clinical-biologic research platform.

    Through study completion, an average of 1 year

Study Arms (1)

Blood specimens

Collection of blood for analysis of various circulating biomarkers in patients with pancreatic adenocarcinoma.

Other: Obtaining blood for analysis of various circulating biomarkers

Interventions

4 tbsp of blood in a 1-week period, occurring no more frequently than 4 times in an 8-week period

Blood specimens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

known or suspected diagnosis of pancreatic adenocarcinoma

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Mark O'Hara, MD

    Abramson Cancer Center, University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 24, 2023

Study Start

February 27, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

January 15, 2028

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations