Genomic Landscape of Intramedullary Astrocytoma

NCT ID: NCT04211974

Last Updated: 2019-12-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-10

Study Completion Date

2023-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intramedullary tumor only account for 2-4% of central nervous tumor. Of which, ependymoma and astrocytoma represent the most common intramedullary tumor. Although intramedullary astrocytoma is rare, it can cause significant mortality and morbidity. Different from its intracranial counterpart which can receive gross total resection and standard adjuvant treatment, intramedullary astrocytoma always cannot be removed completed due to its infiltrative nature and, additionally, radiotherapy and chemotherapy is controversial. Therefore, the treatment for this tumor is very limited. While the genetic profiling of intracranial astrocytoma is relatively well understood and standard treatment strategy has been developed, genetic alteration of intramedullary astrocytoma is less well understood. Identification of the molecular profiling can lead to well understanding of the pathophysiological mechanisms underlying intramedullary astrocytoma and more effective therapeutic strategy in future. Hence, we performed this study aiming to investigate the genetic profiling of intramedullary. All patients with intramedullary astrocytoma underwent surgery in our institution will be enrolled. Tumor tissue and matching blood will be obtained after the surgery. Whole-exome sequencing was performed on DNA extracted from these specimens. Moreover, demographic information, progress-free survival and overall survival will be evaluated in 3 year of follow-up after the initial diagnosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Astrocytoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

spinal cord astrocytoma; whole-exome sequencing;

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

whole-exome sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients that histologically diagnosed as primary spinal cord astrocytoma

Exclusion Criteria

* patients with spinal cord tumors rather than astrocytoma
* metastatic astrocytoma
* tumor sample can not be obtained
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fengzeng Jian

director of neurospine department, Xuanwu hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fengzeng Jian

Role: STUDY_DIRECTOR

Xuanwu Hospital, Capitial Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fengzeng Jiang, M.D.

Role: CONTACT

Phone: +8613552067268

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lei Cheng, M.D.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31565645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29118226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23433793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20526650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16448901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18728568 (View on PubMed)

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.

Reference Type RESULT
PMID: 19898743 (View on PubMed)

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.

Reference Type RESULT
PMID: 22609727 (View on PubMed)

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.

Reference Type RESULT
PMID: 26142051 (View on PubMed)

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.

Reference Type RESULT
PMID: 26235020 (View on PubMed)

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.

Reference Type RESULT
PMID: 23322747 (View on PubMed)

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.

Reference Type RESULT
PMID: 30460627 (View on PubMed)

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.

Reference Type RESULT
PMID: 26443345 (View on PubMed)

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.

Reference Type RESULT
PMID: 31822682 (View on PubMed)

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.

Reference Type RESULT
PMID: 26487540 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Xuanwu-IMA

Identifier Type: -

Identifier Source: org_study_id