AzTrials
AzTrials

Spinal Cord AstrocytomaGIMANCT04211974

Genomic Landscape of Intramedullary Astrocytoma

An observational study of Spinal Cord Astrocytoma, run by Xuanwu Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Spinal Cord Astrocytoma
What is being tested?
whole-exome sequencing
How many people
50 participants
Where
1 siteChina
Study dates
10 Dec 2019to 1 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • patients that histologically diagnosed as primary spinal cord astrocytoma

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Fengzeng Jiang, M.D. contact

+8613552067268

fengzengjiang@hotmail.com

China1 site, 1 recruiting

  • Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

    Beijing, 100053

    Lei Cheng, M.D., +8613718690026, chenglei1865@126.com

    Recruiting

Other trials in China

About this study

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

Read the 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.

Being tested
whole-exome sequencing
Keywords
spinal cord astrocytoma; whole-exome sequencing;

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. molecular profiling results

    mutation identified via whole-exome sequencing will be recored.

    Measured: 1 month after the surgery

Secondary outcomes (2)

  1. 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

    Measured: 3 years after the diagnosis

  2. 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

    Measured: 3 years after the diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start10 Dec 2019
  3. Primary completion10 Dec 2022 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211974
Sponsor's protocol ID
Xuanwu-IMA
Acronym
GIMA
Status last verified
Dec 2019
First submitted
24 Dec 2019
Last updated
26 Dec 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31565645

  • 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.

    PubMed 29118226

  • 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.

    PubMed 23433793

  • 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.

    PubMed 20526650

  • 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.

    PubMed 16448901

  • 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.

    PubMed 18728568

  • 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.

    PubMed 19898743

  • 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.

    PubMed 22609727

  • 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.

    PubMed 26142051

  • 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.

    PubMed 26235020

  • 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.

    PubMed 23322747

  • 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.

    PubMed 30460627

  • 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.

    PubMed 26443345

  • 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.

    PubMed 31822682

  • 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.

    PubMed 26487540

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Astrocytoma, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fengzeng Jiang, M.D. (+8613552067268, fengzengjiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

molecular profiling results (time frame: 1 month after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04211974, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in