Longitudinal Study of Biomarkers

NCT ID: NCT01595126

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2021-05-14

Brief Summary

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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).

Detailed Description

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Conditions

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Central Nervous System Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Central Nervous System Tumors

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rishi Lulla, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Fernandez-L A, Northcott PA, Taylor MD, Kenney AM. Normal and oncogenic roles for microRNAs in the developing brain. Cell Cycle. 2009 Dec 15;8(24):4049-54. doi: 10.4161/cc.8.24.10243. Epub 2009 Dec 5.

Reference Type BACKGROUND
PMID: 19901543 (View on PubMed)

Birks DK, Barton VN, Donson AM, Handler MH, Vibhakar R, Foreman NK. Survey of MicroRNA expression in pediatric brain tumors. Pediatr Blood Cancer. 2011 Feb;56(2):211-6. doi: 10.1002/pbc.22723. Epub 2010 Nov 3.

Reference Type BACKGROUND
PMID: 21157891 (View on PubMed)

Sredni ST, Huang CC, Bonaldo Mde F, Tomita T. MicroRNA expression profiling for molecular classification of pediatric brain tumors. Pediatr Blood Cancer. 2011 Jul 15;57(1):183-4. doi: 10.1002/pbc.23105. Epub 2011 Mar 21. No abstract available.

Reference Type BACKGROUND
PMID: 21425446 (View on PubMed)

Taylor DD, Gercel-Taylor C. MicroRNA signatures of tumor-derived exosomes as diagnostic biomarkers of ovarian cancer. Gynecol Oncol. 2008 Jul;110(1):13-21. doi: 10.1016/j.ygyno.2008.04.033.

Reference Type BACKGROUND
PMID: 18589210 (View on PubMed)

Lawrie CH, Gal S, Dunlop HM, Pushkaran B, Liggins AP, Pulford K, Banham AH, Pezzella F, Boultwood J, Wainscoat JS, Hatton CS, Harris AL. Detection of elevated levels of tumour-associated microRNAs in serum of patients with diffuse large B-cell lymphoma. Br J Haematol. 2008 May;141(5):672-5. doi: 10.1111/j.1365-2141.2008.07077.x. Epub 2008 Mar 3.

Reference Type BACKGROUND
PMID: 18318758 (View on PubMed)

Huang Z, Huang D, Ni S, Peng Z, Sheng W, Du X. Plasma microRNAs are promising novel biomarkers for early detection of colorectal cancer. Int J Cancer. 2010 Jul 1;127(1):118-26. doi: 10.1002/ijc.25007.

Reference Type BACKGROUND
PMID: 19876917 (View on PubMed)

Ng EK, Chong WW, Jin H, Lam EK, Shin VY, Yu J, Poon TC, Ng SS, Sung JJ. Differential expression of microRNAs in plasma of patients with colorectal cancer: a potential marker for colorectal cancer screening. Gut. 2009 Oct;58(10):1375-81. doi: 10.1136/gut.2008.167817. Epub 2009 Feb 6.

Reference Type BACKGROUND
PMID: 19201770 (View on PubMed)

Ji X, Takahashi R, Hiura Y, Hirokawa G, Fukushima Y, Iwai N. Plasma miR-208 as a biomarker of myocardial injury. Clin Chem. 2009 Nov;55(11):1944-9. doi: 10.1373/clinchem.2009.125310. Epub 2009 Aug 20.

Reference Type BACKGROUND
PMID: 19696117 (View on PubMed)

Ai J, Zhang R, Li Y, Pu J, Lu Y, Jiao J, Li K, Yu B, Li Z, Wang R, Wang L, Li Q, Wang N, Shan H, Li Z, Yang B. Circulating microRNA-1 as a potential novel biomarker for acute myocardial infarction. Biochem Biophys Res Commun. 2010 Jan 1;391(1):73-7. doi: 10.1016/j.bbrc.2009.11.005. Epub 2009 Nov 5.

Reference Type BACKGROUND
PMID: 19896465 (View on PubMed)

Das T, Bae YH, Wells A, Roy P. Profilin-1 overexpression upregulates PTEN and suppresses AKT activation in breast cancer cells. J Cell Physiol. 2009 Feb;218(2):436-43. doi: 10.1002/jcp.21618.

Reference Type BACKGROUND
PMID: 18937284 (View on PubMed)

Kolwijck E, Kos J, Obermajer N, Span PN, Thomas CM, Massuger LF, Sweep FC. The balance between extracellular cathepsins and cystatin C is of importance for ovarian cancer. Eur J Clin Invest. 2010 Jul;40(7):591-9. doi: 10.1111/j.1365-2362.2010.02305.x. Epub 2010 May 12.

Reference Type BACKGROUND
PMID: 20482593 (View on PubMed)

Srikantha U, Balasubramaniam A, Santosh V, Somanna S, Bhagavatula ID, Ashwathnarayana CB. Recurrence in medulloblastoma - influence of clinical, histological and immunohistochemical factors. Br J Neurosurg. 2010 Jun;24(3):280-8. doi: 10.3109/02688691003660558.

Reference Type BACKGROUND
PMID: 20465457 (View on PubMed)

Smyth GK. Linear models and empirical bayes methods for assessing differential expression in microarray experiments. Stat Appl Genet Mol Biol. 2004;3:Article3. doi: 10.2202/1544-6115.1027. Epub 2004 Feb 12.

Reference Type BACKGROUND
PMID: 16646809 (View on PubMed)

Liu H, Sadygov RG, Yates JR 3rd. A model for random sampling and estimation of relative protein abundance in shotgun proteomics. Anal Chem. 2004 Jul 15;76(14):4193-201. doi: 10.1021/ac0498563.

Reference Type BACKGROUND
PMID: 15253663 (View on PubMed)

Other Identifiers

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2012-14877

Identifier Type: -

Identifier Source: org_study_id

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