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Healthy Human Control Blood Collection for Validation of Biomarker Assay

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: NCT02302885
Recruitment Status : Suspended (Covid-19)
First Posted : November 27, 2014
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Other: Blood collection

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Blood Collection to Serve as Negative Control for Validation of Circulating Tumor Cell Assay
Study Start Date : November 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • Other: Blood collection
    Blood Collection


Primary Outcome Measures :
  1. blood count [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
About 20 mL blood will be collected from volunteers up to 20 different timepoints.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
cancer-free 18-60 year old men and women
Criteria

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.

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): NCT02302885


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: Jay Dorsey, 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: NCT02302885    
Other Study ID Numbers: UPCC 42914
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
cancer-free 18-60 year old men and women