Genomic Landscape of Intramedullary Astrocytoma

Spinal Cord Astrocytoma Clinical Trial

— GIMA  

Official title:

Genomic Landscape of Intramedullary Astrocytoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211974
• Other study ID #: Xuanwu-IMA
• Status: Recruiting
• Start date: December 10, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2019
• Source: Xuanwu Hospital, Beijing
• Contact: Fengzeng Jiang, M.D.
• Phone: +8613552067268
• Email: fengzengjiang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Spinal Cord Astrocytoma

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
China	Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (15)

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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 — View Citation

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. — View Citation

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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 2 — View Citation

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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. Review. — View Citation

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 th — View Citation

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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 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	molecular profiling results	mutation identified via whole-exome sequencing will be recored.	1 month after the surgery
Secondary	overall survival	overall survival of patients with spinal cord astrocytoma will be recorded;defined as the duration from the date of diagnosis to the date of final follow-up or death	3 years after the diagnosis
Secondary	progression free survival	progression free survival of patients with spinal cord astrocytoma will be recorded;was defined as the duration from the date of diagnosis to the date of tumor progression or death	3 years after the diagnosis