Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research - Full Text View

Purpose

In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other molecules such as proteins and nucleic acids. In patients with central nervous system (CNS) and other conditions, the levels of these molecules may be altered. In several other studies at our institution, the investigators are investigating such molecules in tumor specimens as well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However, these levels are difficult to interpret without comparing them to levels in patients without CNS tumors. The investigators propose a study to collect small amounts of blood and cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.

Condition
Hydrocephalus


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Collection of Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hydrocephalus

Genetic and Rare Diseases Information Center resources: Hydrocephalus Brain Tumor, Childhood

U.S. FDA Resources

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:

levels of miRNAs in the blood and CSF [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survivin and biologic markers levels in the CSF and blood [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

whole blood and cerebrospinal fluid


Enrollment:	5
Study Start Date:	July 2011
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Children without central nervous system tumors Children without central nervous system tumors between the ages of 1 year and 21 years who are undergoing a neurosurgical procedure to address hydrocephalus

Eligibility


Ages Eligible for Study:	1 Year to 21 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All children without central nervous system tumors between the ages of 1 year and 21 years who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will be obtained will be considered

Criteria

Inclusion Criteria:

Children without central nervous system tumors who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will be obtained
Between the ages of 1 year and 21 years
Patients must be having blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs or VPS as part of routine clinical care.

Exclusion Criteria:

Patients who do not require routine blood draws and/or CSF collection as part of their routine clinical care
Patients who are considered too ill to participate as determined by their treating physician
Patients with documented bacterial of viral infections of the CSF, brain parenchyma and/or neurosurgical devices and/or
Patients with suspected de-myelinating conditions
Patients who are pregnant or lactating.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556178

Locations


United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60618

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators


Principal Investigator:	Rishi Lulla, MD	Ann & Robert H Lurie Children's Hospital of Chicago

More Information

Publications:

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. Epub 2009 Dec 5.

Mitchell PS, Parkin RK, Kroh EM, Fritz BR, Wyman SK, Pogosova-Agadjanyan EL, Peterson A, Noteboom J, O'Briant KC, Allen A, Lin DW, Urban N, Drescher CW, Knudsen BS, Stirewalt DL, Gentleman R, Vessella RL, Nelson PS, Martin DB, Tewari M. Circulating microRNAs as stable blood-based markers for cancer detection. Proc Natl Acad Sci U S A. 2008 Jul 29;105(30):10513-8. doi: 10.1073/pnas.0804549105. Epub 2008 Jul 28.

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. Erratum in: Gynecol Oncol. 2010 Jan;116(1):153.

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.

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.

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.

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.

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.

Chakravarti A, Noll E, Black PM, Finkelstein DF, Finkelstein DM, Dyson NJ, Loeffler JS. Quantitatively determined survivin expression levels are of prognostic value in human gliomas. J Clin Oncol. 2002 Feb 15;20(4):1063-8.

Fangusaro JR, Jiang Y, Holloway MP, Caldas H, Singh V, Boué DR, Hayes J, Altura RA. Survivin, Survivin-2B, and Survivin-deItaEx3 expression in medulloblastoma: biologic markers of tumour morphology and clinical outcome. Br J Cancer. 2005 Jan 31;92(2):359-65.

Ikeguchi M, Kaibara N. survivin messenger RNA expression is a good prognostic biomarker for oesophageal carcinoma. Br J Cancer. 2002 Oct 7;87(8):883-7.

Ikeguchi M, Ueda T, Sakatani T, Hirooka Y, Kaibara N. Expression of survivin messenger RNA correlates with poor prognosis in patients with hepatocellular carcinoma. Diagn Mol Pathol. 2002 Mar;11(1):33-40.

Monzó M, Rosell R, Felip E, Astudillo J, Sánchez JJ, Maestre J, Martín C, Font A, Barnadas A, Abad A. A novel anti-apoptosis gene: Re-expression of survivin messenger RNA as a prognosis marker in non-small-cell lung cancers. J Clin Oncol. 1999 Jul;17(7):2100-4.

Mori A, Wada H, Nishimura Y, Okamoto T, Takemoto Y, Kakishita E. Expression of the antiapoptosis gene survivin in human leukemia. Int J Hematol. 2002 Feb;75(2):161-5.

Sarela AI, Verbeke CS, Ramsdale J, Davies CL, Markham AF, Guillou PJ. Expression of survivin, a novel inhibitor of apoptosis and cell cycle regulatory protein, in pancreatic adenocarcinoma. Br J Cancer. 2002 Mar 18;86(6):886-92.

Takamizawa S, Scott D, Wen J, Grundy P, Bishop W, Kimura K, Sandler A. The survivin:fas ratio in pediatric renal tumors. J Pediatr Surg. 2001 Jan;36(1):37-42.

Adida C, Berrebi D, Peuchmaur M, Reyes-Mugica M, Altieri DC. Anti-apoptosis gene, survivin, and prognosis of neuroblastoma. Lancet. 1998 Mar 21;351(9106):882-3.

Islam A, Kageyama H, Takada N, Kawamoto T, Takayasu H, Isogai E, Ohira M, Hashizume K, Kobayashi H, Kaneko Y, Nakagawara A. High expression of Survivin, mapped to 17q25, is significantly associated with poor prognostic factors and promotes cell survival in human neuroblastoma. Oncogene. 2000 Feb 3;19(5):617-23.

Ito R, Asami S, Motohashi S, Ootsuka S, Yamaguchi Y, Chin M, Shichino H, Yoshida Y, Nemoto N, Mugishima H, Suzuki T. Significance of survivin mRNA expression in prognosis of neuroblastoma. Biol Pharm Bull. 2005 Apr;28(4):565-8.


Responsible Party:	Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:	NCT01556178 History of Changes
Other Study ID Numbers:	2011-14612
Study First Received:	February 24, 2012
Last Updated:	February 3, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:


Hydrocephalus Survivin miRNA

Additional relevant MeSH terms:


Brain Neoplasms Hydrocephalus Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site	Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016