NCT01556178

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

February 24, 2012

Last Update Submit

February 3, 2016

Conditions

Hydrocephalus

Keywords

HydrocephalusSurvivinmiRNA

Outcome Measures

Primary Outcomes (1)

  • levels of miRNAs in the blood and CSF

    2 yrs

Secondary Outcomes (1)

  • Survivin and biologic markers levels in the CSF and blood

    2 yrs

Study Arms (1)

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 Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hospital

Chicago, Illinois, 60618, United States

Location

Related Publications (19)

  • 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.

    PMID: 19901543BACKGROUND

  • 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.

    PMID: 18663219BACKGROUND

  • 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.

    PMID: 18589210BACKGROUND

  • 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.

    PMID: 18318758BACKGROUND

  • 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.

    PMID: 19876917BACKGROUND

  • 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.

    PMID: 19201770BACKGROUND

  • 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.

    PMID: 19639033BACKGROUND

  • 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.

    PMID: 19454029BACKGROUND

  • 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. doi: 10.1200/JCO.2002.20.4.1063.

    PMID: 11844831BACKGROUND

  • Fangusaro JR, Jiang Y, Holloway MP, Caldas H, Singh V, Boue 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. doi: 10.1038/sj.bjc.6602317.

    PMID: 15655550BACKGROUND

  • 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. doi: 10.1038/sj.bjc.6600546.

    PMID: 12373603BACKGROUND

  • 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. doi: 10.1097/00019606-200203000-00007.

    PMID: 11854600BACKGROUND

  • Monzo M, Rosell R, Felip E, Astudillo J, Sanchez JJ, Maestre J, Martin 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. doi: 10.1200/JCO.1999.17.7.2100.

    PMID: 10561264BACKGROUND

  • 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. doi: 10.1007/BF02982021.

    PMID: 11939262BACKGROUND

  • 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. doi: 10.1038/sj.bjc.6600133.

    PMID: 11953819BACKGROUND

  • 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. doi: 10.1053/jpsu.2001.20000.

    PMID: 11150435BACKGROUND

  • 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. doi: 10.1016/S0140-6736(05)70294-4. No abstract available.

    PMID: 9525374BACKGROUND

  • 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. doi: 10.1038/sj.onc.1203358.

    PMID: 10698506BACKGROUND

  • 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. doi: 10.1248/bpb.28.565.

    PMID: 15802787BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and cerebrospinal fluid

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rishi Lulla, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 16, 2012

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(1)