Skull Base MeningiomaNCT06319664
Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas
An observational study of Skull Base Meningioma, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. Read more about this study
- Who is it for?
- Ages 15 to 73 years
- Conditions the study is for
- Skull Base Meningioma
- What is being tested?
- retrosigmoid approach (RSA), subtemporal transtentorial transpetrosal approach (STTA) and extended pterional transtentorial approach (EPTA)
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2021to 10 Sep 2021
- 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 15 to 73 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this institutional study, 179 cases of PCM were retrospectively collected and analyzed from January 2011 to December 2020 in our neurosurgical department, Xiangya Hospital, Central South University. This study enrolled 28 males and 151 females with a male to female ratio of 1:5.4 and average age of 49.9±10.2 years (range 15-73 years). A total of 16 cases (8.9%) had been treated in other hospitals preoperatively with 12 cases of prior operations and 4 cases of prior gamma knife radiosurgery (GKS).
Who may be able to join
- diagnosed as the PCM from the MRI follwoed the definition of PCM.
Who cannot join
- 1. combined with serious chronic diseases leading to inoperable therapy; 2. the partient refused to recevie surgical therapy; 3. combined with other cancers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas: a Single Center Report of 179 Cases
Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. We retrospectively analyzed the clinical characteristics, surgical approaches, outcomes and follow-up data from 179 cases of PCM from January 2011 to December 2020. We modified the previous classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P < 0.05 was considered statistically significant.
Read the detailed description
- Study Design and Ethics Approval In this institutional study, 179 cases of PCM were retrospectively collected and analyzed from January 2011 to December 2020 in our neurosurgical department, Xiangya Hospital, Central South University. The studies involving human participants were reviewed and approved by the Ethics Committee of Xiangya Hospital, Central South University (approval no. 202103227) in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments. Patients provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.
- Evaluative Criteria Clinical characteristics with manifestation, neurological function status, neuroimaging and surgical records, and follow-up data were reviewed and evaluated. The preoperative, postoperative and follow-up QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score by two neurosurgeons, independently, on admission, discharge, and follow-up, correspondingly. The preoperative radiological data were obtained from routine examination of brain 3.0 T magnetic resonance imaging (MRI) with T1-weighted, T2-weighted and T1-contrast-enhanced sequences, computed tomography angiography (CTA) and skull base high-resolution computed tomography (HRCT) scans to evaluate tumor size, origin of dural attachment, growth pattern, involved circumjacent range, brainstem displacement, peritumoral edema, encasement of vital neurovascular structure and hydrocephalus to further identify tumor classification and treatment strategy. All of cases were re-examined with contrast MRI to identify the EOR within 72 hours post-operative. The EOR was divided into three levels of gross total resection (GTR) (Simpson Grades I/II), subtotal resection (STR) (Simpson Grades III/IV, with 90-99% excision of the lesion) and partial resection (PR) (Simpson III/IV, with below 90% excision of the lesion), depending on the intraoperative identification and postoperative MRI. A combination of outpatient, telephone and Internet connections were used for follow-up. Follow-up data, including clinical and radiographic information, was collected 3 and 6 months after the surgical procedure and then every 1 or 2 years, in most cases via clinic visits. Questionnaires and phone calls were also carried out. The tumor recurrence or progress (R/P) meant lesion regrowth in situ in GTR cases or residual lesion regrowth with the increase of the maximal diameter more than 3 mm in STR/PR cases. Those who experienced tumor R/P were recommended for additional treatment. The latest follow-up deadline is March 1, 2021.
- PCM Classification On the basis of the variation of PCM pathological alteration in anatomy and with the accumulating experience and incisive comprehension to PCM, we modified and improved our previous tumor classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB).
- Skull Base Approach Choice The skull base approach choice was fundamentally followed by the modified classification. At the same time, the patient's age, request and physical condition cannot be ignored. In this study, the retrosigmoid approach (RSA), subtemporal transtentorial transpetrosal approach (STTA), extended pterional transtentorial approach (EPTA), pretemporal trancavernous anterior transpetrosal approach (PTCA) and presigmoid combined supra-infratentorial approach (PCA) were applied as the main surgical approaches. Moreover, the RSA included basic retrosigmoid approach (BRSA), retrosigmoid trantentorial approach (RTTA) and retrosigmoid intradural suprameatal approach (RISA). Intraoperative neurophysiological monitoring containing somatosensory evoked potentials (SSEP), motor evoked potentials (MEP) and brainstem auditory evoked potentials (BAEP) were essentially and routinely implemented.
- Statistical Analysis Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P < 0.05 was considered statistically significant.
- Conditions
- Skull Base Meningioma
- Being tested
- retrosigmoid approach (RSA), subtemporal transtentorial transpetrosal approach (STTA), extended pterional transtentorial approach (EPTA), pretemporal trancavernous anterior transpetrosal approach (PTCA), presigmoid combined supra-infratentorial approach (PCA)
- Keywords
- clinical outcomes, petroclival meningioma, skull base approach, meningioma classification, operative technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrosigmoid approach (RSA)Procedure or surgery
The skull base approach choice was fundamentally followed by the modified classification.
subtemporal transtentorial transpetrosal approach (STTA)Procedure or surgery
The skull base approach choice was fundamentally followed by the modified classification.
extended pterional transtentorial approach (EPTA)Procedure or surgery
The skull base approach choice was fundamentally followed by the modified classification.
pretemporal trancavernous anterior transpetrosal approach (PTCA)Procedure or surgery
The skull base approach choice was fundamentally followed by the modified classification.
presigmoid combined supra-infratentorial approach (PCA)Procedure or surgery
The skull base approach choice was fundamentally followed by the modified classification.
inoperableProcedure or surgery
The skull base approach choice was fundamentally followed by the modified classification.
| Study group | Role | What they receive |
|---|---|---|
| Clivus type | The dural attachment originates from petroclival fissure, and the main portion of lesion is situated on middle-upper clivus, mainly grows toward the median line and even the heterolateral direction, could involve in the whole clivus region from dorsum sellae to foramen magnum. Receives: Procedure: retrosigmoid approach (RSA) | |
| Petroclival type | The dural attachment originates likewise from petroclival fissure, but primarily extends toward the homolateral dorsal petrosum region, and the main portion is center on middle-upper clivus and grows toward petrous apex region forward and cerebellopontine angle region backward, leading to the homolateral trigeminus being compressed outwards. Receives: Procedure: retrosigmoid approach (RSA) | |
| Petroclivosphenoidal type | The site of origin lies on petroclival region, while the main part of lesion is located in posterior cranial fossa and extends forward and upward along petroclival fissure, and could spread to posterior clinoid process, dorsum sellae and parasellar area with striding petrous ridge, or expanding into Meckel's cave (MC) and even reaching posterior wall of cavernous sinus (CS) through MC. Overall, the growth pattern direction is basically from posterior cranial fossa to middle cranial fossa and from the infratentorial to supratentorial compartment. Receives: Procedure: retrosigmoid approach (RSA); Procedure: subtemporal transtentorial transpetrosal approach (STTA) | |
| Sphenopetroclival Subtype I | Sphenopetroclival type (S-PC type): The site of origin saddles the petrous ridge and invades the CS and parasellar region widely. The growth pattern is different from the PC-S type, mainly from the middle cranial fossa to the posterior cranial fossa. This type is then further classified into two subtypes based on the relationship between CS and the lesion site of origin. Subtype I (S-PC I type): The lesion mainly originates from posterior part of CS and posterior clinoid process region, could invade and break though the CS wall, and the main part of lesion expands towards parasellar, middle cranial fossa, and petrous apex, even invades the dorsum sellae and posterior cranial fossa through tentorium. As a result, the CS wall is mostly rough, and the dural space between the lesion and the temporal lobe is not well-defined on MRI. Receives: Procedure: extended pterional transtentorial approach (EPTA); Procedure: presigmoid combined supra-infratentorial approach (PCA) | |
| Sphenopetroclival Subtype II | The dural attachment of lesion entirely originates within the CS leading to CS region expansile hyperplasia with the virtually intact sinus wall, and part of lesion could spread into the petrous apex and posterior cranial fossa through posterior sinus wall; the large partial lesions may also encroach on the lateral wall of the CS expansion towards the middle cranial fossa. The lateral sinus wall is relatively smooth and maintains the dural space between the lesion and the temporal lobe on MRI. Receives: Procedure: pretemporal trancavernous anterior transpetrosal approach (PTCA); Procedure: presigmoid combined supra-infratentorial approach (PCA) | |
| Central Skull Base type | The dural attachment originates from the petroclival fissure, but growth pattern is widespread invasion of central skull base region and structures bilaterally and the site of origin extensively involves in dorsum sellae, clivus and bilateral suprasellar, parasellar and CS areas even cerebellopontine angle region. Receives: Procedure: inoperable |
What is being measured
The primary outcome is the main question the study is designed to answer.
QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score
QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score by two neurosurgeons, independently, on admission, discharge, and follow-up, correspondingly. Follow-up KPS score was collected through study completion, an average of 1 year, in most cases via clinic visits.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start27 May 2021
- Primary completion10 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skull Base MeningiomaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Liu, MD, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319664
- Sponsor's protocol ID
- sjnkzzj
- Status last verified
- Mar 2021
- First submitted
- 17 Jan 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the research data has been published.
Publications
Research must do no harm: new guidance addresses all studies relating to people. Nature. 2022 Jun;606(7914):434. doi: 10.1038/d41586-022-01607-0. No abstract available.
PubMed 35701624
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas: a Single Center Report of 179 Cases
- ClinicalTrials.gov ID
- NCT06319664
- Acronym / sponsor ID
- sjnkzzj
- Conditions
- Skull Base Meningioma
- Keywords
- clinical outcomes, petroclival meningioma, skull base approach, meningioma classification, operative technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 20 Mar 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.
Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. We retrospectively analyzed the clinical characteristics, surgical approaches, outcomes and follow-up data from 179 cases of PCM from January 2011 to December 2020. We modified the previous classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P < 0.05 was considered statistically significant.
Detailed description
- Study Design and Ethics Approval In this institutional study, 179 cases of PCM were retrospectively collected and analyzed from January 2011 to December 2020 in our neurosurgical department, Xiangya Hospital, Central South University. The studies involving human participants were reviewed and approved by the Ethics Committee of Xiangya Hospital, Central South University (approval no. 202103227) in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments. Patients provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.
- Evaluative Criteria Clinical characteristics with manifestation, neurological function status, neuroimaging and surgical records, and follow-up data were reviewed and evaluated. The preoperative, postoperative and follow-up QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score by two neurosurgeons, independently, on admission, discharge, and follow-up, correspondingly. The preoperative radiological data were obtained from routine examination of brain 3.0 T magnetic resonance imaging (MRI) with T1-weighted, T2-weighted and T1-contrast-enhanced sequences, computed tomography angiography (CTA) and skull base high-resolution computed tomography (HRCT) scans to evaluate tumor size, origin of dural attachment, growth pattern, involved circumjacent range, brainstem displacement, peritumoral edema, encasement of vital neurovascular structure and hydrocephalus to further identify tumor classification and treatment strategy. All of cases were re-examined with contrast MRI to identify the EOR within 72 hours post-operative. The EOR was divided into three levels of gross total resection (GTR) (Simpson Grades I/II), subtotal resection (STR) (Simpson Grades III/IV, with 90-99% excision of the lesion) and partial resection (PR) (Simpson III/IV, with below 90% excision of the lesion), depending on the intraoperative identification and postoperative MRI. A combination of outpatient, telephone and Internet connections were used for follow-up. Follow-up data, including clinical and radiographic information, was collected 3 and 6 months after the surgical procedure and then every 1 or 2 years, in most cases via clinic visits. Questionnaires and phone calls were also carried out. The tumor recurrence or progress (R/P) meant lesion regrowth in situ in GTR cases or residual lesion regrowth with the increase of the maximal diameter more than 3 mm in STR/PR cases. Those who experienced tumor R/P were recommended for additional treatment. The latest follow-up deadline is March 1, 2021.
- PCM Classification On the basis of the variation of PCM pathological alteration in anatomy and with the accumulating experience and incisive comprehension to PCM, we modified and improved our previous tumor classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB).
- Skull Base Approach Choice The skull base approach choice was fundamentally followed by the modified classification. At the same time, the patient's age, request and physical condition cannot be ignored. In this study, the retrosigmoid approach (RSA), subtemporal transtentorial transpetrosal approach (STTA), extended pterional transtentorial approach (EPTA), pretemporal trancavernous anterior transpetrosal approach (PTCA) and presigmoid combined supra-infratentorial approach (PCA) were applied as the main surgical approaches. Moreover, the RSA included basic retrosigmoid approach (BRSA), retrosigmoid trantentorial approach (RTTA) and retrosigmoid intradural suprameatal approach (RISA). Intraoperative neurophysiological monitoring containing somatosensory evoked potentials (SSEP), motor evoked potentials (MEP) and brainstem auditory evoked potentials (BAEP) were essentially and routinely implemented.
- Statistical Analysis Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P < 0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clivus type | – | Procedure: retrosigmoid approach (RSA)The dural attachment originates from petroclival fissure, and the main portion of lesion is situated on middle-upper clivus, mainly grows toward the median line and even the heterolateral direction, could involve in the whole clivus region from dorsum sellae to foramen magnum. |
| Petroclival type | – | Procedure: retrosigmoid approach (RSA)The dural attachment originates likewise from petroclival fissure, but primarily extends toward the homolateral dorsal petrosum region, and the main portion is center on middle-upper clivus and grows toward petrous apex region forward and cerebellopontine angle region backward, leading to the homolateral trigeminus being compressed outwards. |
| Petroclivosphenoidal type | – | Procedure: retrosigmoid approach (RSA), Procedure: subtemporal transtentorial transpetrosal approach (STTA)The site of origin lies on petroclival region, while the main part of lesion is located in posterior cranial fossa and extends forward and upward along petroclival fissure, and could spread to posterior clinoid process, dorsum sellae and parasellar area with striding petrous ridge, or expanding into Meckel's cave (MC) and even reaching posterior wall of cavernous sinus (CS) through MC. Overall, the growth pattern direction is basically from posterior cranial fossa to middle cranial fossa and from the infratentorial to supratentorial compartment. |
| Sphenopetroclival Subtype I | – | Procedure: extended pterional transtentorial approach (EPTA), Procedure: presigmoid combined supra-infratentorial approach (PCA)Sphenopetroclival type (S-PC type): The site of origin saddles the petrous ridge and invades the CS and parasellar region widely. The growth pattern is different from the PC-S type, mainly from the middle cranial fossa to the posterior cranial fossa. This type is then further classified into two subtypes based on the relationship between CS and the lesion site of origin. Subtype I (S-PC I type): The lesion mainly originates from posterior part of CS and posterior clinoid process region, could invade and break though the CS wall, and the main part of lesion expands towards parasellar, middle cranial fossa, and petrous apex, even invades the dorsum sellae and posterior cranial fossa through tentorium. As a result, the CS wall is mostly rough, and the dural space between the lesion and the temporal lobe is not well-defined on MRI. |
| Sphenopetroclival Subtype II | – | Procedure: pretemporal trancavernous anterior transpetrosal approach (PTCA), Procedure: presigmoid combined supra-infratentorial approach (PCA)The dural attachment of lesion entirely originates within the CS leading to CS region expansile hyperplasia with the virtually intact sinus wall, and part of lesion could spread into the petrous apex and posterior cranial fossa through posterior sinus wall; the large partial lesions may also encroach on the lateral wall of the CS expansion towards the middle cranial fossa. The lateral sinus wall is relatively smooth and maintains the dural space between the lesion and the temporal lobe on MRI. |
| Central Skull Base type | – | Procedure: inoperableThe dural attachment originates from the petroclival fissure, but growth pattern is widespread invasion of central skull base region and structures bilaterally and the site of origin extensively involves in dorsum sellae, clivus and bilateral suprasellar, parasellar and CS areas even cerebellopontine angle region. |
Who may qualify
- Ages
- 15 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this institutional study, 179 cases of PCM were retrospectively collected and analyzed from January 2011 to December 2020 in our neurosurgical department, Xiangya Hospital, Central South University. This study enrolled 28 males and 151 females with a male to female ratio of 1:5.4 and average age of 49.9±10.2 years (range 15-73 years). A total of 16 cases (8.9%) had been treated in other hospitals preoperatively with 12 cases of prior operations and 4 cases of prior gamma knife radiosurgery (GKS).
Key inclusion criteria (1 listed)
- diagnosed as the PCM from the MRI follwoed the definition of PCM.
Key exclusion criteria (1 listed)
- 1. combined with serious chronic diseases leading to inoperable therapy; 2. the partient refused to recevie surgical therapy; 3. combined with other cancers.
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 |
|---|---|---|
| retrosigmoid approach (RSA)The skull base approach choice was fundamentally followed by the modified classification. | Procedure or surgery | Clivus type, Petroclival type, Petroclivosphenoidal type |
| subtemporal transtentorial transpetrosal approach (STTA)The skull base approach choice was fundamentally followed by the modified classification. | Procedure or surgery | Petroclivosphenoidal type |
| extended pterional transtentorial approach (EPTA)The skull base approach choice was fundamentally followed by the modified classification. | Procedure or surgery | Sphenopetroclival Subtype I |
| pretemporal trancavernous anterior transpetrosal approach (PTCA)The skull base approach choice was fundamentally followed by the modified classification. | Procedure or surgery | Sphenopetroclival Subtype II |
| presigmoid combined supra-infratentorial approach (PCA)The skull base approach choice was fundamentally followed by the modified classification. | Procedure or surgery | Sphenopetroclival Subtype I, Sphenopetroclival Subtype II |
| inoperableThe skull base approach choice was fundamentally followed by the modified classification. | Procedure or surgery | Central Skull Base type |
Primary outcome
QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score
Time frame: an average of 1 year
QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score by two neurosurgeons, independently, on admission, discharge, and follow-up, correspondingly. Follow-up KPS score was collected through study completion, an average of 1 year, in most cases via clinic visits.
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 20 Mar 2024.
- Results publication: PubMed 35701624Research must do no harm: new guidance addresses all studies relating to people. Nature. 2022 Jun;606(7914):434. doi: 10.1038/d41586-022-01607-0. No abstract available.
- Individual participant dataSharing planned: No. When the research data has been published.
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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.
Qing Liu, MD study director
Xiangya Hospital of Central South University
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 Skull Base Meningioma, run by Xiangya Hospital of Central South University 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 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: finished, as of the sponsor's last update on 20 Mar 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 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?
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?
QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score (time frame: an average of 1 year). 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 NCT06319664, which also lists 1 linked publication.
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 20 Mar 2024.