Circulating microRNAs as Disease Markers in Pediatric Cancers

NCT ID: NCT01541800

Last Updated: 2025-01-24

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-06-30

Brief Summary

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MicroRNAs 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 in normal tissues as well as a wide variety of cancers.

Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to use microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with childhood cancers. We propose a feasibility study to evaluate the presence of microRNAs in the blood and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma who are currently on chemotherapy and undergoing blood draws, lumbar punctures and/or reservoir taps for routine clinical care. If we're able to identify circulating microRNAs in this population of pediatric patients, we will build upon this data in proposing a future study.

Detailed Description

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Conditions

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Leukemia Lymphoma Central Nervous System

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors between 3 years and 21 years of age

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors
* age: greater than 3 years and less than or equal to 21 years of age
* Patients must be in a phase of their treatment during which routine blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs are required for treatment of their cancers.

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 with a known genetic condition that predisposed them to the development of cancer.
Minimum Eligible Age

3 Years

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)

Roth C, Rack B, Muller V, Janni W, Pantel K, Schwarzenbach H. Circulating microRNAs as blood-based markers for patients with primary and metastatic breast cancer. Breast Cancer Res. 2010;12(6):R90. doi: 10.1186/bcr2766. Epub 2010 Nov 3.

Reference Type BACKGROUND
PMID: 21047409 (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)

Heneghan HM, Miller N, Lowery AJ, Sweeney KJ, Kerin MJ. MicroRNAs as Novel Biomarkers for Breast Cancer. J Oncol. 2009;2009:950201. doi: 10.1155/2010/950201. Epub 2009 Jul 20.

Reference Type BACKGROUND
PMID: 19639033 (View on PubMed)

Zhu W, Qin W, Atasoy U, Sauter ER. Circulating microRNAs in breast cancer and healthy subjects. BMC Res Notes. 2009 May 19;2:89. doi: 10.1186/1756-0500-2-89.

Reference Type BACKGROUND
PMID: 19454029 (View on PubMed)

Wang K, Zhang S, Marzolf B, Troisch P, Brightman A, Hu Z, Hood LE, Galas DJ. Circulating microRNAs, potential biomarkers for drug-induced liver injury. Proc Natl Acad Sci U S A. 2009 Mar 17;106(11):4402-7. doi: 10.1073/pnas.0813371106. Epub 2009 Feb 25.

Reference Type BACKGROUND
PMID: 19246379 (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)

Zhang H, Luo XQ, Zhang P, Huang LB, Zheng YS, Wu J, Zhou H, Qu LH, Xu L, Chen YQ. MicroRNA patterns associated with clinical prognostic parameters and CNS relapse prediction in pediatric acute leukemia. PLoS One. 2009 Nov 13;4(11):e7826. doi: 10.1371/journal.pone.0007826.

Reference Type BACKGROUND
PMID: 19915715 (View on PubMed)

Other Identifiers

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2010-14205

Identifier Type: -

Identifier Source: org_study_id

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