High Grade GliomaNCT05850377
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
An observational study of High Grade Glioma and Glioma, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.
Trial summary
The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High Grade Glioma, Glioma, Glioma, Malignant
- What is being tested?
- 5-Aminolevulinic Acid (5-ALA) Gliolan® and Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Jun 2023to 31 May 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-Grade Gliomas patients according to the 2021 World Health Organization (WHO) classification at Instituto Oncológico Nacional Dr. Juan Tanca Marengo
Who may be able to join
- Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
- Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
- Patients with high-grade and residual glioma following surgery for gross total resection
- Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
- Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
- Progressing, low-grade infiltrative gliomas with one of the following criteria:
Show all 9Show fewer
- Anaplastic foci with contrast uptake in MRI
- Spectroscopy study in anaplastic suspected area with high malignancy criteria
- Positive choline PET-CT (positron emission tomography / computer tomography)
Who cannot join
- Tumors extending across midline
- Basal ganglia tumor
- Brainstem tumor
- Multifocal gliomas
- Suspected low-grade glioma without anaplastic foci
- Neuraxial dissemination (ependymoma)
Show all 18Show fewer
- Karnofsky grade less than 60%
- Infants or pregnant women
- Acute or chronic types of porphyria
- Non-acceptance of Fluorescence-Guided Surgery
- Renal insufficiency confirmed by nephrological assessment
- Hepatic impairment confirmed by gastroenterological assessment
- Severe heart disease confirmed by cardiological assessment
- Decompensated diabetes confirmed by endocrinological assessment
- Known allergy to any contrast agent and/or previous history of anaphylactic shock
- Hypersensitivity to the active substance or porphyrins
- Asthma confirmed by pulmonological assessment
- Pacemaker use
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Sociedad de Lucha Contra el Cáncer
Guayaquil, Guayas
Alberto Valarezo Chuchuca, MD, +593 998 686 027, valarezoalb@hotmail.com
Alberto Valarezo Chuchuca, MD
About this study
The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
Read the detailed description
The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.
- Conditions
- High Grade Glioma, Glioma, Glioma, Malignant, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Photosensitizing Agents
- Being tested
- 5-Aminolevulinic Acid (5-ALA) Gliolan®, Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
- Keywords
- High Grade Glioma, 5-ALA, Aminolevulinic Acid, Malignant Glioma, Photodynamic Therapy, Fluorescence-guided Surgery, Photosensitizing Agents, Tumor Resection
- Medical subject headings
- Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Brain Neoplasms, Central Nervous System Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevulinic Acid (5-ALA) Gliolan®Drug
Also called Gliolan®, Gleolan®
Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)Procedure or surgery
During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.
| Study group | Role | What they receive |
|---|---|---|
| Participants with known or suspected High-Grade Gliomas | Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy Receives: Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®; Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free-Survival (PFS)
Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
Measured: 36 months
Secondary outcomes (3)
Overall survival (OS)
Overall survival is defined as time from initiation to death of any cause
Measured: 36 months
Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire
The questionnaire provides an additional set of disease-specific questions pertaining to brain neoplasms. It consists of 46 items that refer to general issues of quality of life and specific to tumor location. Possible scores range from 0 to 108, with higher scores indicating better quality of life.
Measured: 36 months
Average length of hospital stay (ALOS)
The average length of stay in hospitals is often used as an indicator of efficiency. The ALOS refers to the average number of days that patients spend in hospital after surgery. It is calculated by dividing the number of bed-days by the number of discharges after procedure. Average length of stay range from 1 day to 4.5 days. Longer than average stays are usually a symptom of poor communication, quality of care, and effectiveness of treatment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad de Lucha Contra el Cáncer del Ecuador
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Valarezo Chuchuca, MD, Principal investigator, Sociedad de Lucha Contra el Cáncer del Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850377
- Sponsor's protocol ID
- CISOLGYE20230023
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Widhalm G, Minchev G, Woehrer A, Preusser M, Kiesel B, Furtner J, Mert A, Di Ieva A, Tomanek B, Prayer D, Marosi C, Hainfellner JA, Knosp E, Wolfsberger S. Strong 5-aminolevulinic acid-induced fluorescence is a novel intraoperative marker for representative tissue samples in stereotactic brain tumor biopsies. Neurosurg Rev. 2012 Jul;35(3):381-91; discussion 391. doi: 10.1007/s10143-012-0374-5. Epub 2012 Mar 10.
PubMed 22407140Nitta T, Sato K. Prognostic implications of the extent of surgical resection in patients with intracranial malignant gliomas. Cancer. 1995 Jun 1;75(11):2727-31. doi: 10.1002/1097-0142(19950601)75:113.0.co;2-h.
PubMed 7743477Lacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, Hess K, Michael C, Miller D, Sawaya R. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001 Aug;95(2):190-8. doi: 10.3171/jns.2001.95.2.0190.
PubMed 11780887Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
PubMed 16648043Inoue T, Endo T, Nagamatsu K, Watanabe M, Tominaga T. 5-aminolevulinic acid fluorescence-guided resection of intramedullary ependymoma: report of 9 cases. Neurosurgery. 2013 Jun;72(2 Suppl Operative):ons159-68; discussion ons168. doi: 10.1227/NEU.0b013e31827bc7a3.
PubMed 23149963Eicker SO, Floeth FW, Kamp M, Steiger HJ, Hanggi D. The impact of fluorescence guidance on spinal intradural tumour surgery. Eur Spine J. 2013 Jun;22(6):1394-401. doi: 10.1007/s00586-013-2657-0. Epub 2013 Jan 10.
PubMed 23307195Beez T, Sarikaya-Seiwert S, Steiger HJ, Hanggi D. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of brain tumors in children--a technical report. Acta Neurochir (Wien). 2014 Mar;156(3):597-604. doi: 10.1007/s00701-014-1997-9. Epub 2014 Jan 22.
PubMed 24449149Eicker S, Sarikaya-Seiwert S, Borkhardt A, Gierga K, Turowski B, Heiroth HJ, Steiger HJ, Stummer W. ALA-induced porphyrin accumulation in medulloblastoma and its use for fluorescence-guided surgery. Cent Eur Neurosurg. 2011 May;72(2):101-3. doi: 10.1055/s-0030-1252010. Epub 2010 Oct 7. No abstract available.
PubMed 20931449Foster N, Eljamel S. ALA-induced fluorescence image guided surgery of meningiomas: A meta-analyses. Photodiagnosis Photodyn Ther. 2016 Sep;15:73-8. doi: 10.1016/j.pdpdt.2016.05.006. Epub 2016 May 24.
PubMed 27235278Wainwright JV, Endo T, Cooper JB, Tominaga T, Schmidt MH. The role of 5-aminolevulinic acid in spinal tumor surgery: a review. J Neurooncol. 2019 Feb;141(3):575-584. doi: 10.1007/s11060-018-03080-0. Epub 2018 Dec 29.
PubMed 30594965Esteves S, Alves M, Castel-Branco M, Stummer W. A pilot cost-effectiveness analysis of treatments in newly diagnosed high-grade gliomas: the example of 5-aminolevulinic Acid compared with white-light surgery. Neurosurgery. 2015 May;76(5):552-62; discussion 562. doi: 10.1227/NEU.0000000000000673.
PubMed 25714513Lau D, Hervey-Jumper SL, Chang S, Molinaro AM, McDermott MW, Phillips JJ, Berger MS. A prospective Phase II clinical trial of 5-aminolevulinic acid to assess the correlation of intraoperative fluorescence intensity and degree of histologic cellularity during resection of high-grade gliomas. J Neurosurg. 2016 May;124(5):1300-9. doi: 10.3171/2015.5.JNS1577. Epub 2015 Nov 6.
PubMed 26544781Kaneko S, Kaneko S. Fluorescence-Guided Resection of Malignant Glioma with 5-ALA. Int J Biomed Imaging. 2016;2016:6135293. doi: 10.1155/2016/6135293. Epub 2016 Jun 27.
PubMed 27429612Cozzens JW, Lokaitis BC, Moore BE, Amin DV, Espinosa JA, MacGregor M, Michael AP, Jones BA. A Phase 1 Dose-Escalation Study of Oral 5-Aminolevulinic Acid in Adult Patients Undergoing Resection of a Newly Diagnosed or Recurrent High-Grade Glioma. Neurosurgery. 2017 Jul 1;81(1):46-55. doi: 10.1093/neuros/nyw182.
PubMed 28498936Acerbi F, Broggi M, Schebesch KM, Hohne J, Cavallo C, De Laurentis C, Eoli M, Anghileri E, Servida M, Boffano C, Pollo B, Schiariti M, Visintini S, Montomoli C, Bosio L, La Corte E, Broggi G, Brawanski A, Ferroli P. Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO). Clin Cancer Res. 2018 Jan 1;24(1):52-61. doi: 10.1158/1078-0432.CCR-17-1184. Epub 2017 Oct 10.
PubMed 29018053
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT05850377
- Acronym / sponsor ID
- CISOLGYE20230023
- Conditions
- High Grade Glioma, Glioma, Glioma, Malignant, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Photosensitizing Agents
- Keywords
- High Grade Glioma, 5-ALA, Aminolevulinic Acid, Malignant Glioma, Photodynamic Therapy, Fluorescence-guided Surgery, Photosensitizing Agents, Tumor Resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sociedad de Lucha Contra el Cáncer del EcuadorUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
Detailed description
The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with known or suspected High-Grade Gliomas | – | Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®, Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-Grade Gliomas patients according to the 2021 World Health Organization (WHO) classification at Instituto Oncológico Nacional Dr. Juan Tanca Marengo
Key inclusion criteria (9 listed)
- Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
- Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
- Patients with high-grade and residual glioma following surgery for gross total resection
- Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
- Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
Key exclusion criteria (18 listed)
- Tumors extending across midline
- Basal ganglia tumor
- Brainstem tumor
- Multifocal gliomas
- Suspected low-grade glioma without anaplastic foci
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Aminolevulinic Acid (5-ALA) Gliolan®Also: Gliolan®, Gleolan®Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl. | Drug | Participants with known or suspected High-Grade Gliomas |
| Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected. | Procedure or surgery | Participants with known or suspected High-Grade Gliomas |
Primary outcome
Disease-Free-Survival (PFS)
Time frame: 36 months
Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
3 secondary outcomes
Overall survival (OS)
Time frame: 36 months
Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire
Time frame: 36 months
Average length of hospital stay (ALOS)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 22407140Widhalm G, Minchev G, Woehrer A, Preusser M, Kiesel B, Furtner J, Mert A, Di Ieva A, Tomanek B, Prayer D, Marosi C, Hainfellner JA, Knosp E, Wolfsberger S. Strong 5-aminolevulinic acid-induced fluorescence is a novel intraoperative marker for representative tissue samples in stereotactic brain tumor biopsies. Neurosurg Rev. 2012 Jul;35(3):381-91; discussion 391. doi: 10.1007/s10143-012-0374-5. Epub 2012 Mar 10.
- Background: PubMed 7743477Nitta T, Sato K. Prognostic implications of the extent of surgical resection in patients with intracranial malignant gliomas. Cancer. 1995 Jun 1;75(11):2727-31. doi: 10.1002/1097-0142(19950601)75:113.0.co;2-h.
- Background: PubMed 11780887Lacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, Hess K, Michael C, Miller D, Sawaya R. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001 Aug;95(2):190-8. doi: 10.3171/jns.2001.95.2.0190.
- Background: PubMed 16648043Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
- Background: PubMed 23149963Inoue T, Endo T, Nagamatsu K, Watanabe M, Tominaga T. 5-aminolevulinic acid fluorescence-guided resection of intramedullary ependymoma: report of 9 cases. Neurosurgery. 2013 Jun;72(2 Suppl Operative):ons159-68; discussion ons168. doi: 10.1227/NEU.0b013e31827bc7a3.
- Background: PubMed 23307195Eicker SO, Floeth FW, Kamp M, Steiger HJ, Hanggi D. The impact of fluorescence guidance on spinal intradural tumour surgery. Eur Spine J. 2013 Jun;22(6):1394-401. doi: 10.1007/s00586-013-2657-0. Epub 2013 Jan 10.
- Background: PubMed 24449149Beez T, Sarikaya-Seiwert S, Steiger HJ, Hanggi D. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of brain tumors in children--a technical report. Acta Neurochir (Wien). 2014 Mar;156(3):597-604. doi: 10.1007/s00701-014-1997-9. Epub 2014 Jan 22.
- Background: PubMed 20931449Eicker S, Sarikaya-Seiwert S, Borkhardt A, Gierga K, Turowski B, Heiroth HJ, Steiger HJ, Stummer W. ALA-induced porphyrin accumulation in medulloblastoma and its use for fluorescence-guided surgery. Cent Eur Neurosurg. 2011 May;72(2):101-3. doi: 10.1055/s-0030-1252010. Epub 2010 Oct 7. No abstract available.
- Background: PubMed 27235278Foster N, Eljamel S. ALA-induced fluorescence image guided surgery of meningiomas: A meta-analyses. Photodiagnosis Photodyn Ther. 2016 Sep;15:73-8. doi: 10.1016/j.pdpdt.2016.05.006. Epub 2016 May 24.
- Background: PubMed 30594965Wainwright JV, Endo T, Cooper JB, Tominaga T, Schmidt MH. The role of 5-aminolevulinic acid in spinal tumor surgery: a review. J Neurooncol. 2019 Feb;141(3):575-584. doi: 10.1007/s11060-018-03080-0. Epub 2018 Dec 29.
- Background: PubMed 25714513Esteves S, Alves M, Castel-Branco M, Stummer W. A pilot cost-effectiveness analysis of treatments in newly diagnosed high-grade gliomas: the example of 5-aminolevulinic Acid compared with white-light surgery. Neurosurgery. 2015 May;76(5):552-62; discussion 562. doi: 10.1227/NEU.0000000000000673.
- Background: PubMed 26544781Lau D, Hervey-Jumper SL, Chang S, Molinaro AM, McDermott MW, Phillips JJ, Berger MS. A prospective Phase II clinical trial of 5-aminolevulinic acid to assess the correlation of intraoperative fluorescence intensity and degree of histologic cellularity during resection of high-grade gliomas. J Neurosurg. 2016 May;124(5):1300-9. doi: 10.3171/2015.5.JNS1577. Epub 2015 Nov 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Valarezo Chuchuca, MD principal investigator
Sociedad de Lucha Contra el Cáncer del Ecuador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Glioma and Glioma, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.
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 9 inclusion and 18 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 9 May 2023. 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 Ecuador. 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 Alberto Valarezo Chuchuca, MD (+593 998 686 027, valarezoalb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free-Survival (PFS) (time frame: 36 months). 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 NCT05850377, which also lists 25 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 9 May 2023.