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Longitudinal Study of Biomarkers

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ClinicalTrials.gov Identifier: NCT01595126
Recruitment Status : Unknown
Verified February 2016 by Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was:  Recruiting
First Posted : May 9, 2012
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago

Study Description
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Brief Summary:

Biomarkers are small molecules that can be detected in the body fluids of patients; they often correlate with the presence of a cancer. MicroRNAs and proteins are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs and proteins in normal tissues as well as a wide variety of cancers.

Recently, microRNAs and proteins from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to use microRNAs and proteins in the blood as an early predictor of cancer as well as a marker of response to therapy. Previous work in our labs have identified miRNAs and proteins in the blood and cerebrospinal fluid (CSF) of pediatric patients with brain tumors.

To determine a longitudinal evaluation of the presence of microRNAs and proteins in the blood, cerebrospinal fluid and urine of patients with central nervous system tumors from diagnosis through the course of their treatment. Though the duration of active treatment varies significantly based upon the diagnosis, patients will be followed for up to 24 months after enrollment onto the study).


Condition or disease
Central Nervous System Tumor

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Longitudinal Study of Biomarkers in Pediatric Patients With Central Nervous System Tumors
Study Start Date : December 2011
Estimated Primary Completion Date : December 2018
Groups and Cohorts
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Group/Cohort
Patients with Central Nervous System Tumors


Outcome Measures
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Primary Outcome Measures :
  1. Presence of microRNAs and proteins in the blood, cerebrospinal fluid and urine of patients with central nervous system tumors from diagnosis through the course of their treatment [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed patients with central nervous system tumors
Criteria

Inclusion Criteria:

  • Patients ages 1 day to 21 years
  • Patients with radiographically and/or histologically confirmed CNS tumors treated at Children's Memorial Hospital and Lurie Children's Hospital in Chicago
  • Patients must be newly diagnosed and have had no prior anticancer therapy (except surgery) for their current diagnosis. The use of steroids is permissible.
  • Patients and/or parents/legal guardians must have signed an informed consent and assent when applicable.

Exclusion Criteria:

  • Patients who have completed treatment and do not require routine blood draws and/or lumbar punctures
  • Patients who are considered too ill to participate as determined by their treating physician
  • Patients who are pregnant or lactating
Contacts and Locations
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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): NCT01595126


Contacts
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Contact: Margaret Nevins 312.227.4861 mnevins@luriechildrens.org

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Margaret Nevins    312-227-4861    mnevins@luriechildrens.org   
Principal Investigator: Rishi Lulla, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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Principal Investigator: Rishi Lulla, MD Ann & Robert H Lurie Children's Hospital of Chicago
More Information
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Publications:

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Responsible Party: Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01595126    
Other Study ID Numbers: 2012-14877
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases