Healthy Human Control Blood Collection for Validation of Biomarker Assay

January 28, 2026 updated by: Abramson Cancer Center at Penn Medicine

Human Blood Collection to Serve as Negative Control for Validation of Circulating Tumor Cell Assay

Human blood will be collected to serve as control in validating clinical studies studying the detection and levels of circulating tumor cells and microvesicles in cancer patients. Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort, bruising) to the volunteer.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Other: Blood collection

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center of the 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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

cancer-free 18-60 year old men and women

Description

Inclusion Criteria:

Age range: 18-60 years old Gender: Male and Female

Exclusion Criteria:

No previously diagnosed malignancy Age: It is important to obtain a healthy, cancer-free volunteer population to serve as negative controls for this detection assay.

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood count Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

Principal Investigator: Jay Dorsey, MD, Abramson Cancer Center at Penn Medicine

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)

November 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimated)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

cancer-free 18-60 year old men and women

Additional Relevant MeSH Terms

Other Study ID Numbers

UPCC 42914

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.