GlioblastomaNCT06348693
Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness
An observational study of Glioblastoma and Glioma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma, Glioma, Glioma Glioblastoma Multiforme
- What is being tested?
- cell isolation from tumor biopsies and biomarker investigation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 19 Apr 2017to 21 Nov 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Considering the high heterogeneity of gliomas in relation to age, sex, surgical radicality, WHO performance status, MGMT methylation, molecular and biochemical characteristics, to demonstrate a benefit of the treatments that will be administered to stem and endothelial cells it will be necessary to consider a high sample size to allow for adequate subgroup analysis and to generate reliable data. To this end, the investigators will begin the study by analyzing 400 subjects affected by glioma.
Who may be able to join
- Patients with glioma diagnosed histologically confirmed (WHO) undergoing surgical resection;
- hypomethylation or hypermethylation of MGMT assessed post-surgery for patients affected by GBM;
- adult patients (≥18 years), both sexes;
- Patients undergoing Stupp protocol including patients aged > 70 years performing the hypofractionated protocol and three weeks of chemotherapy;
- Karnofsky Performance Status (KPS)> 60 assessed post-surgery;
- freely given written informed consent prior to any activity related to the study. erine
Who cannot join
- patients who do not sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Stefania E Navone, PhD, 0255034268 ext. +39, stefania.navone@policlinico.mi.it
Giovanni Marfia, MD, PhD, 0255034268 ext. +39, giovanni.marfia@policlinico.mi.it
About this study
Official title: Strategies for the Development of Multimodal Therapies in Tumors of the Central Nervous System: Identification of New Molecular and Metabolic Targets Implicated in Survival and Chemoresistance Involving Endothelial and Cancer Stem Cells
Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).
S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.
The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment.
Read the detailed description
Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Among tumors of the central nervous system, Glioblastoma (GBM) is the most frequent and aggressive malignant tumor with an average life expectancy of approximately 12 months and a survival of less than 5% in the following 5 years to the diagnosis. The growth and progression of GBM are dependent on a specialized subpopulation of tumor cells called "cancer stem cells" (CSCs). CSCs are chemo- and radio-resistant, are responsible for relapses and therefore should constitute an important target of therapeutic strategies, but the mechanisms underlying their biology are still poorly understood. Hypoxia, through the hypoxia-inducible factor (HIF) and sphingolipid pathway, plays a key role in the control of tumor growth and angiogenesis and represents, perhaps, the most effective adaptation mechanism of the tumor itself. Indeed, The hypoxic microenvironment of solid tumors gives them greater aggressiveness, an increase in the expression of proteins linked to angiogenesis, anaerobic energy metabolism and adaptation to oxidative stress which facilitates the onset and proliferation of CSCs.
This study supports the evidence that the hypoxic microenvironment regulates the state of CSCs, and therefore influencing the response to the current pharmacological treatments.
Although S1P can act as an intracellular second messenger, most of its effects are exerted as an extracellular mediator, through binding to specific G protein-coupled receptors, originally known as EDGs and now called S1P receptors (S1PRs). Our group has previously demonstrated that acquired modifications in the metabolism of sphingolipids, in particular in the regulation of S1P, are able to confer stem-like and chemo-resistance properties to CSCs in patients with GBM.
The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment.
Through the study of sphingolipid metabolism, new markers and inhibitors will be identified to be delivered to inhibit CSC proliferation and tumor progression.
With this approach the investigators will be able to evaluate how the tumor microenvironment and the molecular and metabolic characteristics of the tumor influence cellular communication and whether this process can be influenced by new pharmacological treatments. This study could highlight new pathways and tumor-specific alterations to stratify new therapeutic strategies and to identify new potential biomarkers in diagnosis and monitoring, thus improving the prognosis of patients suffering from brain tumors.
- Conditions
- Glioblastoma, Glioma, Glioma Glioblastoma Multiforme
- Being tested
- cell isolation from tumor biopsies and biomarker investigation
- Keywords
- cancer stem cells, tumor endothelial cells, sphingolipids, sphingosine-1-phosphate, platelets, biomarkers
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell isolation from tumor biopsies and biomarker investigationOther
cellular and molecular analysis on cancer stem cells and endothelial cells from tumor biopsies and investigation of tissue and systemic biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Glioma | Patients affected by brain tumors undergoing surgical resection; hypomethylation or hypermethylation of MGMT assessed post-surgery for patients affected by GBM; adult patients (≥18 years), both sexes; Patients undergoing Stupp protocol including patients aged > 70 years performing the hypofractionated protocol and three weeks of chemotherapy; Karnofsky Performance Status (KPS)> 60 assessed post-surgery; freely given written informed consent prior to any activity related to the study. Receives: Other: cell isolation from tumor biopsies and biomarker investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis.
Evaluation of prognostic and predictive role of molecular and metabolic markers of the tumor. Determination of gene and protein expression of a panel of markers related to stemness, angiogenesis/hypoxia, and sphingolipid signaling.
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
Biomarker investigation
Identification of new tissue and circulating biomarkers with predictive and prognostic significance
Measured: Through study completion, an average of 3 years
Cellular response to pharmacological treatments
Investigation of cellular response following new treatments determined by molecular and metabolic specific signature; determination of a panel of markers differently expressed following pharmacological treatments; evaluation of the prognostic and predictive role of tumor marker expression
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start19 Apr 2017
- Primary completion21 Nov 2025 (estimated)
- Study completion21 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Locatelli, MD, PhD, Study director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoGiovanni Marfia, MD, PhD, Study chair, Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico, Istituto di Medicina Aerospaziale di Milano-Aeronautica MilitareStefania E Navone, PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348693
- Sponsor's protocol ID
- Gliotherapy
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marfia G, Navone SE, Fanizzi C, Tabano S, Pesenti C, Abdel Hadi L, Franzini A, Caroli M, Miozzo M, Riboni L, Rampini P, Campanella R. Prognostic value of preoperative von Willebrand factor plasma levels in patients with Glioblastoma. Cancer Med. 2016 Aug;5(8):1783-90. doi: 10.1002/cam4.747. Epub 2016 May 28.
PubMed 27236861Navone SE, Guarnaccia L, Rizzaro MD, Begani L, Barilla E, Alotta G, Garzia E, Caroli M, Ampollini A, Violetti A, Gervasi N, Campanella R, Riboni L, Locatelli M, Marfia G. Role of Luteolin as Potential New Therapeutic Option for Patients with Glioblastoma through Regulation of Sphingolipid Rheostat. Int J Mol Sci. 2023 Dec 21;25(1):130. doi: 10.3390/ijms25010130.
PubMed 38203299Guarnaccia M, Guarnaccia L, La Cognata V, Navone SE, Campanella R, Ampollini A, Locatelli M, Miozzo M, Marfia G, Cavallaro S. A Targeted Next-Generation Sequencing Panel to Genotype Gliomas. Life (Basel). 2022 Jun 24;12(7):956. doi: 10.3390/life12070956.
PubMed 35888045Campanella R, Guarnaccia L, Caroli M, Zarino B, Carrabba G, La Verde N, Gaudino C, Rampini A, Luzzi S, Riboni L, Locatelli M, Navone SE, Marfia G. Personalized and translational approach for malignant brain tumors in the era of precision medicine: the strategic contribution of an experienced neurosurgery laboratory in a modern neurosurgery and neuro-oncology department. J Neurol Sci. 2020 Oct 15;417:117083. doi: 10.1016/j.jns.2020.117083. Epub 2020 Aug 6.
PubMed 32784071Riboni L, Abdel Hadi L, Navone SE, Guarnaccia L, Campanella R, Marfia G. Sphingosine-1-Phosphate in the Tumor Microenvironment: A Signaling Hub Regulating Cancer Hallmarks. Cells. 2020 Feb 1;9(2):337. doi: 10.3390/cells9020337.
PubMed 32024090Campanella R, Guarnaccia L, Cordiglieri C, Trombetta E, Caroli M, Carrabba G, La Verde N, Rampini P, Gaudino C, Costa A, Luzzi S, Mantovani G, Locatelli M, Riboni L, Navone SE, Marfia G. Tumor-Educated Platelets and Angiogenesis in Glioblastoma: Another Brick in the Wall for Novel Prognostic and Targetable Biomarkers, Changing the Vision from a Localized Tumor to a Systemic Pathology. Cells. 2020 Jan 25;9(2):294. doi: 10.3390/cells9020294.
PubMed 31991805Abdel Hadi L, Anelli V, Guarnaccia L, Navone S, Beretta M, Moccia F, Tringali C, Urechie V, Campanella R, Marfia G, Riboni L. A bidirectional crosstalk between glioblastoma and brain endothelial cells potentiates the angiogenic and proliferative signaling of sphingosine-1-phosphate in the glioblastoma microenvironment. Biochim Biophys Acta Mol Cell Biol Lipids. 2018 Oct;1863(10):1179-1192. doi: 10.1016/j.bbalip.2018.07.009. Epub 2018 Jul 26.
PubMed 30056170Marfia G, Campanella R, Navone SE, Di Vito C, Riccitelli E, Hadi LA, Bornati A, de Rezende G, Giussani P, Tringali C, Viani P, Rampini P, Alessandri G, Parati E, Riboni L. Autocrine/paracrine sphingosine-1-phosphate fuels proliferative and stemness qualities of glioblastoma stem cells. Glia. 2014 Dec;62(12):1968-81. doi: 10.1002/glia.22718. Epub 2014 Jul 5.
PubMed 25042636Navone SE, Marfia G, Invernici G, Cristini S, Nava S, Balbi S, Sangiorgi S, Ciusani E, Bosutti A, Alessandri G, Slevin M, Parati EA. Isolation and expansion of human and mouse brain microvascular endothelial cells. Nat Protoc. 2013 Sep;8(9):1680-93. doi: 10.1038/nprot.2013.107. Epub 2013 Aug 8.
PubMed 23928501
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for the Development of Multimodal Therapies in Tumors of the Central Nervous System: Identification of New Molecular and Metabolic Targets Implicated in Survival and Chemoresistance Involving Endothelial and Cancer Stem Cells
- ClinicalTrials.gov ID
- NCT06348693
- Acronym / sponsor ID
- Gliotherapy
- Conditions
- Glioblastoma, Glioma, Glioma Glioblastoma Multiforme
- Keywords
- cancer stem cells, tumor endothelial cells, sphingolipids, sphingosine-1-phosphate, platelets, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 21 Nov 2025 (estimated)
- Study completion
- 21 Nov 2025 (estimated)
- First posted
- 5 Apr 2024 (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.
Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).
S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.
The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment.
Detailed description
Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Among tumors of the central nervous system, Glioblastoma (GBM) is the most frequent and aggressive malignant tumor with an average life expectancy of approximately 12 months and a survival of less than 5% in the following 5 years to the diagnosis. The growth and progression of GBM are dependent on a specialized subpopulation of tumor cells called "cancer stem cells" (CSCs). CSCs are chemo- and radio-resistant, are responsible for relapses and therefore should constitute an important target of therapeutic strategies, but the mechanisms underlying their biology are still poorly understood. Hypoxia, through the hypoxia-inducible factor (HIF) and sphingolipid pathway, plays a key role in the control of tumor growth and angiogenesis and represents, perhaps, the most effective adaptation mechanism of the tumor itself. Indeed, The hypoxic microenvironment of solid tumors gives them greater aggressiveness, an increase in the expression of proteins linked to angiogenesis, anaerobic energy metabolism and adaptation to oxidative stress which facilitates the onset and proliferation of CSCs.
This study supports the evidence that the hypoxic microenvironment regulates the state of CSCs, and therefore influencing the response to the current pharmacological treatments.
Although S1P can act as an intracellular second messenger, most of its effects are exerted as an extracellular mediator, through binding to specific G protein-coupled receptors, originally known as EDGs and now called S1P receptors (S1PRs). Our group has previously demonstrated that acquired modifications in the metabolism of sphingolipids, in particular in the regulation of S1P, are able to confer stem-like and chemo-resistance properties to CSCs in patients with GBM.
The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment.
Through the study of sphingolipid metabolism, new markers and inhibitors will be identified to be delivered to inhibit CSC proliferation and tumor progression.
With this approach the investigators will be able to evaluate how the tumor microenvironment and the molecular and metabolic characteristics of the tumor influence cellular communication and whether this process can be influenced by new pharmacological treatments. This study could highlight new pathways and tumor-specific alterations to stratify new therapeutic strategies and to identify new potential biomarkers in diagnosis and monitoring, thus improving the prognosis of patients suffering from brain tumors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioma | – | Other: cell isolation from tumor biopsies and biomarker investigationPatients affected by brain tumors undergoing surgical resection; hypomethylation or hypermethylation of MGMT assessed post-surgery for patients affected by GBM; adult patients (≥18 years), both sexes; Patients undergoing Stupp protocol including patients aged > 70 years performing the hypofractionated protocol and three weeks of chemotherapy; Karnofsky Performance Status (KPS)> 60 assessed post-surgery; freely given written informed consent prior to any activity related to the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Considering the high heterogeneity of gliomas in relation to age, sex, surgical radicality, WHO performance status, MGMT methylation, molecular and biochemical characteristics, to demonstrate a benefit of the treatments that will be administered to stem and endothelial cells it will be necessary to consider a high sample size to allow for adequate subgroup analysis and to generate reliable data. To this end, the investigators will begin the study by analyzing 400 subjects affected by glioma.
Key inclusion criteria (6 listed)
- Patients with glioma diagnosed histologically confirmed (WHO) undergoing surgical resection;
- hypomethylation or hypermethylation of MGMT assessed post-surgery for patients affected by GBM;
- adult patients (≥18 years), both sexes;
- Patients undergoing Stupp protocol including patients aged > 70 years performing the hypofractionated protocol and three weeks of chemotherapy;
- Karnofsky Performance Status (KPS)> 60 assessed post-surgery;
Key exclusion criteria (1 listed)
- patients who do not sign the informed consent
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 |
|---|---|---|
| cell isolation from tumor biopsies and biomarker investigationcellular and molecular analysis on cancer stem cells and endothelial cells from tumor biopsies and investigation of tissue and systemic biomarkers | Other | Glioma |
Primary outcome
Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis.
Time frame: Through study completion, an average of 3 years
Evaluation of prognostic and predictive role of molecular and metabolic markers of the tumor. Determination of gene and protein expression of a panel of markers related to stemness, angiogenesis/hypoxia, and sphingolipid signaling.
2 secondary outcomes
Biomarker investigation
Time frame: Through study completion, an average of 3 years
Cellular response to pharmacological treatments
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 27236861Marfia G, Navone SE, Fanizzi C, Tabano S, Pesenti C, Abdel Hadi L, Franzini A, Caroli M, Miozzo M, Riboni L, Rampini P, Campanella R. Prognostic value of preoperative von Willebrand factor plasma levels in patients with Glioblastoma. Cancer Med. 2016 Aug;5(8):1783-90. doi: 10.1002/cam4.747. Epub 2016 May 28.
- Results publication: PubMed 38203299Navone SE, Guarnaccia L, Rizzaro MD, Begani L, Barilla E, Alotta G, Garzia E, Caroli M, Ampollini A, Violetti A, Gervasi N, Campanella R, Riboni L, Locatelli M, Marfia G. Role of Luteolin as Potential New Therapeutic Option for Patients with Glioblastoma through Regulation of Sphingolipid Rheostat. Int J Mol Sci. 2023 Dec 21;25(1):130. doi: 10.3390/ijms25010130.
- Results publication: PubMed 35888045Guarnaccia M, Guarnaccia L, La Cognata V, Navone SE, Campanella R, Ampollini A, Locatelli M, Miozzo M, Marfia G, Cavallaro S. A Targeted Next-Generation Sequencing Panel to Genotype Gliomas. Life (Basel). 2022 Jun 24;12(7):956. doi: 10.3390/life12070956.
- Results publication: PubMed 32784071Campanella R, Guarnaccia L, Caroli M, Zarino B, Carrabba G, La Verde N, Gaudino C, Rampini A, Luzzi S, Riboni L, Locatelli M, Navone SE, Marfia G. Personalized and translational approach for malignant brain tumors in the era of precision medicine: the strategic contribution of an experienced neurosurgery laboratory in a modern neurosurgery and neuro-oncology department. J Neurol Sci. 2020 Oct 15;417:117083. doi: 10.1016/j.jns.2020.117083. Epub 2020 Aug 6.
- Results publication: PubMed 32024090Riboni L, Abdel Hadi L, Navone SE, Guarnaccia L, Campanella R, Marfia G. Sphingosine-1-Phosphate in the Tumor Microenvironment: A Signaling Hub Regulating Cancer Hallmarks. Cells. 2020 Feb 1;9(2):337. doi: 10.3390/cells9020337.
- Results publication: PubMed 31991805Campanella R, Guarnaccia L, Cordiglieri C, Trombetta E, Caroli M, Carrabba G, La Verde N, Rampini P, Gaudino C, Costa A, Luzzi S, Mantovani G, Locatelli M, Riboni L, Navone SE, Marfia G. Tumor-Educated Platelets and Angiogenesis in Glioblastoma: Another Brick in the Wall for Novel Prognostic and Targetable Biomarkers, Changing the Vision from a Localized Tumor to a Systemic Pathology. Cells. 2020 Jan 25;9(2):294. doi: 10.3390/cells9020294.
- Results publication: PubMed 30056170Abdel Hadi L, Anelli V, Guarnaccia L, Navone S, Beretta M, Moccia F, Tringali C, Urechie V, Campanella R, Marfia G, Riboni L. A bidirectional crosstalk between glioblastoma and brain endothelial cells potentiates the angiogenic and proliferative signaling of sphingosine-1-phosphate in the glioblastoma microenvironment. Biochim Biophys Acta Mol Cell Biol Lipids. 2018 Oct;1863(10):1179-1192. doi: 10.1016/j.bbalip.2018.07.009. Epub 2018 Jul 26.
- Results publication: PubMed 25042636Marfia G, Campanella R, Navone SE, Di Vito C, Riccitelli E, Hadi LA, Bornati A, de Rezende G, Giussani P, Tringali C, Viani P, Rampini P, Alessandri G, Parati E, Riboni L. Autocrine/paracrine sphingosine-1-phosphate fuels proliferative and stemness qualities of glioblastoma stem cells. Glia. 2014 Dec;62(12):1968-81. doi: 10.1002/glia.22718. Epub 2014 Jul 5.
- Results publication: PubMed 23928501Navone SE, Marfia G, Invernici G, Cristini S, Nava S, Balbi S, Sangiorgi S, Ciusani E, Bosutti A, Alessandri G, Slevin M, Parati EA. Isolation and expansion of human and mouse brain microvascular endothelial cells. Nat Protoc. 2013 Sep;8(9):1680-93. doi: 10.1038/nprot.2013.107. Epub 2013 Aug 8.
- website Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoLink provided by the sponsor.
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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.
Marco Locatelli, MD, PhD study director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Giovanni Marfia, MD, PhD study chair
Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico, Istituto di Medicina Aerospaziale di Milano-Aeronautica Militare
Stefania E Navone, PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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 Glioblastoma and Glioma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 6 inclusion and 1 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 5 Apr 2024. 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 Italy. 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 Stefania E Navone, PhD (0255034268 ext. +39, stefania.navone@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis. (time frame: Through study completion, an average of 3 years). 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 NCT06348693, which also lists 9 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 5 Apr 2024.