NCT04211974

Brief Summary

intramedullary astrocytoma is a rare and devastating spinal cord glioma. while the management of intracranial astrocytoma includes gross total resection, radiotherapy and chemotherapy, spinal cord astrocytoma is very difficult to be totally removed due to its infiltrative nature and unclear plane of dissection; Moreover, the use radiotherapy and chemotherapy for spinal cord astrocytoma is controversial. Therefore, the treatment for spinal cord astrocytoma is very limited as compared to its intracranial counterpart. Inadequate understanding of spinal cord astrocytoma mainly contribute to limited treatment, while the molecular profiling of intracranial astrocytoma is relatively well understood. Hence, we performed whole-exome sequencing of intramedullary astrocytoma aiming to identify the pathophysiological mechanisms underlying spinal cord astrocytoma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 10, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

December 24, 2019

Last Update Submit

December 24, 2019

Conditions

Spinal Cord Astrocytoma

Keywords

spinal cord astrocytoma; whole-exome sequencing;

Outcome Measures

Primary Outcomes (1)

  • molecular profiling results

    mutation identified via whole-exome sequencing will be recored.

    1 month after the surgery

Secondary Outcomes (2)

  • overall survival

    3 years after the diagnosis

  • progression free survival

    3 years after the diagnosis

Interventions

whole-exome sequencingDIAGNOSTIC_TEST

Fresh frozen or formalin-fixed, paraffin-embedded samples were obtained from patients following resection along with matching peripheral blood samples. whole-exome sequencing will be performed to identify mutations in tumor tissue and matching blood

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who was histologically diagnosed as primary spinal cord astrocytoma or was suspected of primary spinal cord astrocytoma will be enrolled. But patiens who was suspected of primary spinal cord astrocytoma preoperatively but was confirmed as tumor rather than astrocytoma postoperatively via histology will be excluded.

You may qualify if:

  • patients that histologically diagnosed as primary spinal cord astrocytoma

You may not qualify if:

  • patients with spinal cord tumors rather than astrocytoma
  • metastatic astrocytoma
  • tumor sample can not be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Beijing, 100053, China

RECRUITING

Related Publications (15)

  • Ogunlade J, Wiginton JG 4th, Elia C, Odell T, Rao SC. Primary Spinal Astrocytomas: A Literature Review. Cureus. 2019 Jul 26;11(7):e5247. doi: 10.7759/cureus.5247.

    PMID: 31565645BACKGROUND

  • Nabors LB, Portnow J, Ammirati M, Baehring J, Brem H, Butowski N, Fenstermaker RA, Forsyth P, Hattangadi-Gluth J, Holdhoff M, Howard S, Junck L, Kaley T, Kumthekar P, Loeffler JS, Moots PL, Mrugala MM, Nagpal S, Pandey M, Parney I, Peters K, Puduvalli VK, Ragsdale J, Rockhill J, Rogers L, Rusthoven C, Shonka N, Shrieve DC, Sills AK, Swinnen LJ, Tsien C, Weiss S, Wen PY, Willmarth N, Bergman MA, Engh A. NCCN Guidelines Insights: Central Nervous System Cancers, Version 1.2017. J Natl Compr Canc Netw. 2017 Nov;15(11):1331-1345. doi: 10.6004/jnccn.2017.0166.

    PMID: 29118226BACKGROUND

  • Guss ZD, Moningi S, Jallo GI, Cohen KJ, Wharam MD, Terezakis SA. Management of pediatric spinal cord astrocytomas: outcomes with adjuvant radiation. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1307-11. doi: 10.1016/j.ijrobp.2012.11.022. Epub 2013 Feb 20.

    PMID: 23433793BACKGROUND

  • Kim WH, Yoon SH, Kim CY, Kim KJ, Lee MM, Choe G, Kim IA, Kim JH, Kim YJ, Kim HJ. Temozolomide for malignant primary spinal cord glioma: an experience of six cases and a literature review. J Neurooncol. 2011 Jan;101(2):247-54. doi: 10.1007/s11060-010-0249-y. Epub 2010 Jun 5.

    PMID: 20526650BACKGROUND

  • Chi JH, Cachola K, Parsa AT. Genetics and molecular biology of intramedullary spinal cord tumors. Neurosurg Clin N Am. 2006 Jan;17(1):1-5. doi: 10.1016/j.nec.2005.10.002. No abstract available.

    PMID: 16448901BACKGROUND

  • McGirt MJ, Goldstein IM, Chaichana KL, Tobias ME, Kothbauer KF, Jallo GI. Extent of surgical resection of malignant astrocytomas of the spinal cord: outcome analysis of 35 patients. Neurosurgery. 2008 Jul;63(1):55-60; discussion 60-1. doi: 10.1227/01.NEU.0000335070.37943.09.

    PMID: 18728568BACKGROUND

  • Milano MT, Johnson MD, Sul J, Mohile NA, Korones DN, Okunieff P, Walter KA. Primary spinal cord glioma: a Surveillance, Epidemiology, and End Results database study. J Neurooncol. 2010 May;98(1):83-92. doi: 10.1007/s11060-009-0054-7. Epub 2009 Nov 7.

    PMID: 19898743RESULT

  • Adams H, Avendano J, Raza SM, Gokaslan ZL, Jallo GI, Quinones-Hinojosa A. Prognostic factors and survival in primary malignant astrocytomas of the spinal cord: a population-based analysis from 1973 to 2007. Spine (Phila Pa 1976). 2012 May 20;37(12):E727-35. doi: 10.1097/BRS.0b013e31824584c0.

    PMID: 22609727RESULT

  • Liu A, Sankey EW, Bettegowda C, Burger PC, Jallo GI, Groves ML. Poor prognosis despite aggressive treatment in adults with intramedullary spinal cord glioblastoma. J Clin Neurosci. 2015 Oct;22(10):1628-31. doi: 10.1016/j.jocn.2015.05.008. Epub 2015 Jun 30.

    PMID: 26142051RESULT

  • Karsy M, Guan J, Sivakumar W, Neil JA, Schmidt MH, Mahan MA. The genetic basis of intradural spinal tumors and its impact on clinical treatment. Neurosurg Focus. 2015 Aug;39(2):E3. doi: 10.3171/2015.5.FOCUS15143.

    PMID: 26235020RESULT

  • Fakhreddine MH, Mahajan A, Penas-Prado M, Weinberg J, McCutcheon IE, Puduvalli V, Brown PD. Treatment, prognostic factors, and outcomes in spinal cord astrocytomas. Neuro Oncol. 2013 Apr;15(4):406-12. doi: 10.1093/neuonc/nos309. Epub 2013 Jan 14.

    PMID: 23322747RESULT

  • Moinuddin FM, Alvi MA, Kerezoudis P, Wahood W, Meyer J, Lachance DH, Bydon M. Variation in management of spinal gliobastoma multiforme: results from a national cancer registry. J Neurooncol. 2019 Jan;141(2):441-447. doi: 10.1007/s11060-018-03054-2. Epub 2018 Nov 20.

    PMID: 30460627RESULT

  • Shows J, Marshall C, Perry A, Kleinschmidt-DeMasters BK. Genetics of Glioblastomas in Rare Anatomical Locations: Spinal Cord and Optic Nerve. Brain Pathol. 2016 Jan;26(1):120-3. doi: 10.1111/bpa.12327. No abstract available.

    PMID: 26443345RESULT

  • Zhang M, Iyer RR, Azad TD, Wang Q, Garzon-Muvdi T, Wang J, Liu A, Burger P, Eberhart C, Rodriguez FJ, Sciubba DM, Wolinsky JP, Gokaslan Z, Groves ML, Jallo GI, Bettegowda C. Genomic Landscape of Intramedullary Spinal Cord Gliomas. Sci Rep. 2019 Dec 10;9(1):18722. doi: 10.1038/s41598-019-54286-9.

    PMID: 31822682RESULT

  • Shankar GM, Lelic N, Gill CM, Thorner AR, Van Hummelen P, Wisoff JH, Loeffler JS, Brastianos PK, Shin JH, Borges LF, Butler WE, Zagzag D, Brody RI, Duhaime AC, Taylor MD, Hawkins CE, Louis DN, Cahill DP, Curry WT, Meyerson M. BRAF alteration status and the histone H3F3A gene K27M mutation segregate spinal cord astrocytoma histology. Acta Neuropathol. 2016 Jan;131(1):147-50. doi: 10.1007/s00401-015-1492-2. No abstract available.

    PMID: 26487540RESULT

Biospecimen

Retention: SAMPLES WITH DNA

tumor resected and matched blood

MeSH Terms

Interventions

Exome

Intervention Hierarchy (Ancestors)

GenomeGenetic StructuresGenetic Phenomena

Study Officials

  • Fengzeng Jian

    Xuanwu Hospital, Capitial Medical University

    STUDY DIRECTOR

Central Study Contacts

Fengzeng Jiang, M.D.

CONTACT

+8613552067268fengzengjiang@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of neurospine department, Xuanwu hospital

Study Record Dates

First Submitted

December 24, 2019

First Posted

December 26, 2019

Study Start

December 10, 2019

Primary Completion

December 10, 2022

Study Completion

January 1, 2023

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

CN(1)