GlioblastomaGLIOSUPPORTNCT04516733
Precoce Medical Care by the Mobil Support for Patients With Glioblastoma
A study testing supportive care in people with Glioblastoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life. This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2019to 15 Feb 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient ( ≥ 18 years),
- Histological diagnosis of Glioblastoma
- Oncology caret at ICM (regardless of treatment: Stupp protocol, chemotherapy alone, targeted therapy, etc.);
- Patient consent signed after informed information.
Who cannot join
- Patient unable to consent to the study
- Major impairment of the general health : performance status OMS =4;
- Patient not affiliated with a French social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life.
This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.
Read more
In this context, and despite the lack of impact on overall survival, improving quality of life becomes a priority objective in recent Phase III trials.
The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.
Read the detailed description
glioblastomas are the most common primary malignant tumours of the central nervous system.They represent about 2000 new cases per year in France.
Despite active treatments including surgery, radiotherapy and chemotherapy, patient survival is limited without possible cure.
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life. Exploration of verbal memory in these patients shows that its deterioration is correlated with a more unfavourable prognosis, after adjustment with other usual prognostic factors.
This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.
The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.
- Conditions
- Glioblastoma
- Being tested
- supportive care
- Keywords
- supportive care, mobil unit
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supportive careOther
visit with supportiv unit and neuropsychologue every 3 months
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | patient with glioblastoma Receives: Other: supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit.
Compliance is defined as the proportion of patients attending three palliative care unit visits (Ve1, Ve2 and Ve3).
Measured: from date of inclusion visit until an average of 3 months
Secondary outcomes (13)
The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)
Participation rate, defined as the proportion of patients who accepted inclusion in the study among all screened patients. Investigator expect an 80% participation rate in this study
Measured: at the inclusion visit
Proportion of patients completing all quality of life assessments (QLQ-C30 (Quality Life Questionnaire) at palliative care unit visits (Ve1, Ve2 and Ve3)
The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit
Measured: from date of inclusion visit until an average of 3 months
Proportion of patients completing all BN20 assessments (Brain Cancer Module) at palliative care unit visits (Ve1, Ve2 and Ve3)
The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit
Measured: from date of inclusion visit until an average of 3 months
Proportion of patients completing all anxiety assessments (HADS, Hospital Anxiety and Depression Scale) at palliative care unit visits (Ve1, Ve2 and Ve3)
The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit
Measured: from date of inclusion visit until an average of 3 months
Changes over time in patients' quality of life
Score of questionnaire (QLQ-C30 (Quality Life Questionnaire)
Measured: from date of inclusion visit until an average of 3 months
Changes over time in patients' quality of life
Score of questionnaire BN20 (Brain Cancer Module)
Measured: from date of inclusion visit until an average of 3 months
The evolution over time of anxiety and depressive affects in patients
score of HADS questionnaire (Hospital Anxiety and Depression Scale). <9 no significant, between 10 and12 limit and > 13 significant
Measured: from date of inclusion visit until an average of 3 months
The evolution over time of neurocognitive performance in patients and the delay before neurocognitive degradation (Mattis DRS scale);
Neurocognitive performance of patients assessed by total score and scores at sub-scales of attention, initiation, conceptualization, construction and memory at the Mattis DRS scale
Measured: from date of inclusion visit until an average of 3 months
Rate of patients who have written advance directives since the diagnostic announcement;
The percentage of patients for whom advance directives have been written and documented in the medical record,
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Rate of patients who have designated a support person since the diagnostic announcement
the percentage of patients for whom the support person has been designated
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
proportion of patients receiving specific medical oncology treatment in their last month of life
Percentage of patients receiving specific oncology treatment in the month prior to death
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
defined as the delay between the date of inclusion and the date of death (any cause) or the date of last update
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The proportion of patients diagnosed with glioblastoma that are available for this medical care
Percentage of patients diagnosed with glioblastoma not care at the center during the inclusion period will be reported, as well as the reasons for not cared at the ICM center
Measured: at the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start10 May 2019
- Primary completion15 Sep 2020
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- in addition to oncology care, there will be a care with palliative team and neuropsychological care
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel FABBRO, MD, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516733
- Sponsor's protocol ID
- PROICM 2018-04 GLI
- Acronym
- GLIOSUPPORT
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.
PubMed 23940216Brown PD, Ballman KV, Rummans TA, Maurer MJ, Sloan JA, Boeve BF, Gupta L, Tang-Wai DF, Arusell RM, Clark MM, Buckner JC. Prospective study of quality of life in adults with newly diagnosed high-grade gliomas. J Neurooncol. 2006 Feb;76(3):283-91. doi: 10.1007/s11060-005-7020-9.
PubMed 16163448Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
PubMed 8445433Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.
PubMed 24552318Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daude H, Tretarre B, Bauchet F, Duffau H, Taillandier L, Bauchet L. Epidemiology for primary brain tumors: a nationwide population-based study. J Neurooncol. 2017 Feb;131(3):525-546. doi: 10.1007/s11060-016-2318-3. Epub 2016 Nov 16.
PubMed 27853959Flechl B, Ackerl M, Sax C, Dieckmann K, Crevenna R, Gaiger A, Widhalm G, Preusser M, Marosi C. Neurocognitive and sociodemographic functioning of glioblastoma long-term survivors. J Neurooncol. 2012 Sep;109(2):331-9. doi: 10.1007/s11060-012-0897-1. Epub 2012 May 29.
PubMed 22644537Flechl B, Sax C, Ackerl M, Crevenna R, Woehrer A, Hainfellner J, Preusser M, Widhalm G, Kiesel B, Lutgendorf-Caucig C, Dieckmann K, Steffal C, Marosi C, Hassler MR. The course of quality of life and neurocognition in newly diagnosed patients with glioblastoma. Radiother Oncol. 2017 Nov;125(2):228-233. doi: 10.1016/j.radonc.2017.07.027. Epub 2017 Aug 8.
PubMed 28801008Gilbert MR. Antiangiogenic Therapy for Glioblastoma: Complex Biology and Complicated Results. J Clin Oncol. 2016 May 10;34(14):1567-9. doi: 10.1200/JCO.2016.66.5364. Epub 2016 Mar 21. No abstract available.
PubMed 27001588Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.
PubMed 24552317
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment
- ClinicalTrials.gov ID
- NCT04516733
- Acronym / sponsor ID
- GLIOSUPPORT / PROICM 2018-04 GLI
- Conditions
- Glioblastoma
- Keywords
- supportive care, mobil unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 18 Aug 2020 (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.
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life.
This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.
In this context, and despite the lack of impact on overall survival, improving quality of life becomes a priority objective in recent Phase III trials.
The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.
Detailed description
glioblastomas are the most common primary malignant tumours of the central nervous system.They represent about 2000 new cases per year in France.
Despite active treatments including surgery, radiotherapy and chemotherapy, patient survival is limited without possible cure.
Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life. Exploration of verbal memory in these patients shows that its deterioration is correlated with a more unfavourable prognosis, after adjustment with other usual prognostic factors.
This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.
The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- in addition to oncology care, there will be a care with palliative team and neuropsychological care
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: supportive carepatient with glioblastoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient ( ≥ 18 years),
- Histological diagnosis of Glioblastoma
- Oncology caret at ICM (regardless of treatment: Stupp protocol, chemotherapy alone, targeted therapy, etc.);
- Patient consent signed after informed information.
Key exclusion criteria (3 listed)
- Patient unable to consent to the study
- Major impairment of the general health : performance status OMS =4;
- Patient not affiliated with a French social security
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 |
|---|---|---|
| supportive carevisit with supportiv unit and neuropsychologue every 3 months | Other | single arm |
Primary outcome
Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit.
Time frame: from date of inclusion visit until an average of 3 months
Compliance is defined as the proportion of patients attending three palliative care unit visits (Ve1, Ve2 and Ve3).
13 secondary outcomes
The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)
Time frame: at the inclusion visit
Proportion of patients completing all quality of life assessments (QLQ-C30 (Quality Life Questionnaire) at palliative care unit visits (Ve1, Ve2 and Ve3)
Time frame: from date of inclusion visit until an average of 3 months
Proportion of patients completing all BN20 assessments (Brain Cancer Module) at palliative care unit visits (Ve1, Ve2 and Ve3)
Time frame: from date of inclusion visit until an average of 3 months
Proportion of patients completing all anxiety assessments (HADS, Hospital Anxiety and Depression Scale) at palliative care unit visits (Ve1, Ve2 and Ve3)
Time frame: from date of inclusion visit until an average of 3 months
Changes over time in patients' quality of life
Time frame: from date of inclusion visit until an average of 3 months
Changes over time in patients' quality of life
Time frame: from date of inclusion visit until an average of 3 months
The evolution over time of anxiety and depressive affects in patients
Time frame: from date of inclusion visit until an average of 3 months
The evolution over time of neurocognitive performance in patients and the delay before neurocognitive degradation (Mattis DRS scale);
Time frame: from date of inclusion visit until an average of 3 months
Rate of patients who have written advance directives since the diagnostic announcement;
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Rate of patients who have designated a support person since the diagnostic announcement
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
proportion of patients receiving specific medical oncology treatment in their last month of life
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The proportion of patients diagnosed with glioblastoma that are available for this medical care
Time frame: at the inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Results publication: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Results publication: PubMed 23940216Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.
- Results publication: PubMed 16163448Brown PD, Ballman KV, Rummans TA, Maurer MJ, Sloan JA, Boeve BF, Gupta L, Tang-Wai DF, Arusell RM, Clark MM, Buckner JC. Prospective study of quality of life in adults with newly diagnosed high-grade gliomas. J Neurooncol. 2006 Feb;76(3):283-91. doi: 10.1007/s11060-005-7020-9.
- Results publication: PubMed 8445433Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Results publication: PubMed 24552318Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.
- Results publication: PubMed 27853959Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daude H, Tretarre B, Bauchet F, Duffau H, Taillandier L, Bauchet L. Epidemiology for primary brain tumors: a nationwide population-based study. J Neurooncol. 2017 Feb;131(3):525-546. doi: 10.1007/s11060-016-2318-3. Epub 2016 Nov 16.
- Results publication: PubMed 22644537Flechl B, Ackerl M, Sax C, Dieckmann K, Crevenna R, Gaiger A, Widhalm G, Preusser M, Marosi C. Neurocognitive and sociodemographic functioning of glioblastoma long-term survivors. J Neurooncol. 2012 Sep;109(2):331-9. doi: 10.1007/s11060-012-0897-1. Epub 2012 May 29.
- Results publication: PubMed 28801008Flechl B, Sax C, Ackerl M, Crevenna R, Woehrer A, Hainfellner J, Preusser M, Widhalm G, Kiesel B, Lutgendorf-Caucig C, Dieckmann K, Steffal C, Marosi C, Hassler MR. The course of quality of life and neurocognition in newly diagnosed patients with glioblastoma. Radiother Oncol. 2017 Nov;125(2):228-233. doi: 10.1016/j.radonc.2017.07.027. Epub 2017 Aug 8.
- Results publication: PubMed 27001588Gilbert MR. Antiangiogenic Therapy for Glioblastoma: Complex Biology and Complicated Results. J Clin Oncol. 2016 May 10;34(14):1567-9. doi: 10.1200/JCO.2016.66.5364. Epub 2016 Mar 21. No abstract available.
- Results publication: PubMed 24552317Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.
- 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.
Michel FABBRO, MD study chair
Institut du Cancer de Montpellier - Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supportive care in people with Glioblastoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 14 Mar 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit. (time frame: from date of inclusion visit until an average of 3 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 NCT04516733, which also lists 10 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 14 Mar 2022.