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Genomic Landscape of Intramedullary Astrocytoma (GIMA)

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ClinicalTrials.gov Identifier: NCT04211974
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Fengzeng Jian, Xuanwu Hospital, Beijing

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

Condition or disease Intervention/treatment
Spinal Cord Astrocytoma Diagnostic Test: whole-exome sequencing

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genomic Landscape of Intramedullary Astrocytoma
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 10, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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



Primary Outcome Measures :
  1. molecular profiling results [ Time Frame: 1 month after the surgery ]
    mutation identified via whole-exome sequencing will be recored.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years after the diagnosis ]
    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

  2. progression free survival [ Time Frame: 3 years after the diagnosis ]
    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


Biospecimen Retention:   Samples With DNA
tumor resected and matched blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211974


Contacts
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Contact: Fengzeng Jiang, M.D. +8613552067268 fengzengjiang@hotmail.com

Locations
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China
Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University Recruiting
Beijing, China, 100053
Contact: Lei Cheng, M.D.    +8613718690026    chenglei1865@126.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Director: Fengzeng Jian Xuanwu Hospital, Capitial Medical University
Publications of Results:

Other Publications:

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Responsible Party: Fengzeng Jian, director of neurospine department, Xuanwu hospital, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT04211974    
Other Study ID Numbers: Xuanwu-IMA
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fengzeng Jian, Xuanwu Hospital, Beijing:
spinal cord astrocytoma; whole-exome sequencing;
Additional relevant MeSH terms:
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Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue