GlioblastomaNCT06845020
CSF Proteomic Characterization of Glioblastomas
An observational study of Glioblastoma and Glioblastoma WHO Grade IV, run by Univeridad Autonoma de Guadalajara.
Trial summary
The goal of this observational study is to identify proteins that can be found in the cerebrospinal fluid (CSF) of patients with grade IV brain tumors, specifically glioblastomas, and correlate these proteins with progression free survival, overall survival and performance status (functionality). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma WHO Grade IV, Glioblastoma (GBM)
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Mar 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patient population includes patients who arrive at the Hospital Regional 'Dr. Valentin Gomez Farias' ISSSTE, who have a high probability of glioblastoma diagnosis, based on clinical presentation and imaging. Additionally the population includes 5 patients whose samples and information has already been stored at the Mayo Clinic Florida.
Who may be able to join
- Patients with confirmed diagnosis of glioblastoma (histopathological and molecular).
- Patients who voluntarily accept participation in this study.
- Patients aged 18 or older.
Who cannot join
- Patients who cannot be followed up at the Regional Hospital 'Dr. Valentin Gomez Farias' ISSSTE.
- Contamination of the required sample (CSF, serum, tumor).
- Patients with whom no sampling was obtained or subjects with incomplete background information.
- Patients who decide to withdraw participation from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile
The goal of this observational study is to identify proteins that can be found in the cerebrospinal fluid (CSF) of patients with grade IV brain tumors, specifically glioblastomas, and correlate these proteins with progression free survival, overall survival and performance status (functionality). All participants with high probability of glioblastoma will initially be included, final inclusion will be dependent on the definitive histopathological diagnosis of the tumor.
The main question is:
Read more
Can the researchers identify a proteomic profile in CSF from study participants with glioblastoma in association with a longer progression free survival? Participants will undergo the following procedures, that do not deviate from normal standard diagnostic care.
- Lumbar puncture to obtain CSF.
- Blood draw.
- Trans-surgical tissue sample of the brain tumor. Additionally participants will be planned for follow up appointments every 3 months following the first 12 months after the surgical tumor resection.
Read the detailed description
To successfully complete the study the following procedures will be implemented after obtaining informed consent:
- Serum blood sample acquisition and storage
- CSF sample acquisition Of all subjects included in the study a CSF sample will be taken. The sampling will be pre-surgical by lumbar puncture. Before the lumbar puncture all patients will undergo brain imaging (CT or MRI), as well as an fundoscopic exam and a blood draw. Through patient history and clinical examination other neurological pathology is discarded (neurological focalization, altered mental status, recent seizures or any other previous or recent neurological pathology). Patients with lumbar puncture contraindications as sampling method will undergo trans-surgical sampling, as initial procedure performed during surgery to avoid contamination. All sampling must be taken before any radio- and/or chemotherapy.
- Storage of sampled CSF The CSF sample obtained will be minimally 3 mL (3 tubes of 1 mL), in sterile tubes without any type of additives. The sample will be stored at -80 °C.
- Tumour tissue acquisition and storage Of all subjects included in the study, tumour tissue samples will be obtained from the central zone, posteriorly molecular analysis and identification of coding genes for significant proteins in CSF will be performed with MALDI-TOF.
After obtaining the patient background information and the tissue samples (CSF, tumour and serum) genetic and histological testing will be performed to obtain glioblastoma diagnosis, following current guidelines, the next parameters must be present for definitive glioblastoma diagnosis, and thus inclusion in the study:
- IDH-Wildtype diffuse and astrocytic glioma in adults
+ microvascular proliferation or necrosis OR + TERT promotor mutation OR + EFGR gene amplification OR + +7/-10 chromosome copy number changes. When definitive diagnosis is obtained and inclusion in this study is confirmed there will be programmed follow-up visits at 3, 6, 9 and 12 months, where a previously designed questionnaire similar to the admission questionnaire will be performed to specify patient evolution, and functionality current adjuvant treatment, additionally a full physical exam including neurological exam will be performed, with a radiological imaging study (CT or MRI). In case of decease, this will be closely registered by contacting the patient or family one week before the follow-up appointment to confirm the appointment, in case of deceasement date and cause must be registered.
Statistical Analysis:
For the descriptive phase of the statistical analysis, it is intended to use the mean and standard deviation for the variables with parametric distribution and the median with Interquartile range for the variables with non-parametric distribution. Qualitative variables such as protein identification will be reported in frequencies and percentages. The inferential phase includes the creation of contingency tables and chi square. For the analysis of progression-free survival and overall survival, Kaplan Meier curves will be used.
- Conditions
- Glioblastoma, Glioblastoma WHO Grade IV, Glioblastoma (GBM), Glioblastoma Multiforme of the Brain, Glioblastoma, Adult
- Keywords
- Glioblastoma, Cerebrospinal fluid, CSF, GBM, Proteomics, Biomarker
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with definitive diagnosis of glioblastoma | The cohort includes patients with a histopathological diagnosis of glioblastoma, defined by the 2021 guidelines: IDH-Wildtype diffuse and astrocytic glioma in adults + microvascular proliferation or necrosis OR + TERT promotor mutation OR + EFGR gene amplification OR + +7/-10 chromosome copy number changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The length of time the participants are still alive after tumor resection (initial recruitment date), including disease progression.
Measured: Measured at 3, 6, 9, and 12 months, after participant recruitment.
Secondary outcomes (2)
Progression free survival
Progression free survival is defined by the amount of time the patient lives with glioblastoma from the start of treatment (surgical resection) without progression of disease.
Progression of disease is defined as follows: an increase in tumor size, or; new cancerous lesiones on imaging, or; a non-measurable increase of malignant disease (eg.: paraneoplastic syndrome).
Measured: Measured at 3, 6, 9, and 12 months, after participant recruitment.
Performance status
The Karnofsky performance status (KPS) will be used to measure the functionality of patients with cancer, and their ability to perform daily tasks. This be used this as a measurement of disease progression and to correlate different KPS with the proteomics found. The KPS scale measures patients performance on a scale from 0 to 100% with 10% intervals, 0% meaning patient deceased and 100% normal activity, without signs of disease.
Measured: Measured at baseline, 3, 6, 9, and 12 months, after participant recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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
- 15 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Univeridad Autonoma de Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Hospital Valentin Gomez Farias
- Responsible party
- Principal investigator, Maria G. Zavala-Cerna, Univeridad Autonoma de Guadalajara
- Investigators
- Maria Guadalupe Zavala Cerna, MD, PhD, Principal investigator, Universidad Autónoma de GuadalajaraHugo Guerrero Cazares, MD, PhD, Study chair, Mayo Clinic Jacksonville, Florida.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845020
- Sponsor's protocol ID
- T05-273-1324-4794-19-00
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmid D, Warnken U, Latzer P, Hoffmann DC, Roth J, Kutschmann S, Jaschonek H, Rubmann P, Foltyn M, Vollmuth P, Winkler F, Seliger C, Felix M, Sahm F, Haas J, Reuss D, Bendszus M, Wildemann B, von Deimling A, Wick W, Kessler T. Diagnostic biomarkers from proteomic characterization of cerebrospinal fluid in patients with brain malignancies. J Neurochem. 2021 Jul;158(2):522-538. doi: 10.1111/jnc.15350. Epub 2021 Apr 9.
PubMed 33735443Skog J, Wurdinger T, van Rijn S, Meijer DH, Gainche L, Sena-Esteves M, Curry WT Jr, Carter BS, Krichevsky AM, Breakefield XO. Glioblastoma microvesicles transport RNA and proteins that promote tumour growth and provide diagnostic biomarkers. Nat Cell Biol. 2008 Dec;10(12):1470-6. doi: 10.1038/ncb1800. Epub 2008 Nov 16.
PubMed 19011622Schuhmann MU, Zucht HD, Nassimi R, Heine G, Schneekloth CG, Stuerenburg HJ, Selle H. Peptide screening of cerebrospinal fluid in patients with glioblastoma multiforme. Eur J Surg Oncol. 2010 Feb;36(2):201-7. doi: 10.1016/j.ejso.2009.07.010. Epub 2009 Aug 11.
PubMed 19674866Jayaram S, Gupta MK, Polisetty RV, Cho WC, Sirdeshmukh R. Towards developing biomarkers for glioblastoma multiforme: a proteomics view. Expert Rev Proteomics. 2014 Oct;11(5):621-39. doi: 10.1586/14789450.2014.939634. Epub 2014 Aug 13.
PubMed 25115191Kohata T, Ito S, Masuda T, Furuta T, Nakada M, Ohtsuki S. Laminin Subunit Alpha-4 and Osteopontin Are Glioblastoma-Selective Secreted Proteins That Are Increased in the Cerebrospinal Fluid of Glioblastoma Patients. J Proteome Res. 2020 Aug 7;19(8):3542-3553. doi: 10.1021/acs.jproteome.0c00415. Epub 2020 Jul 16.
PubMed 32628487Hori T, Sasayama T, Tanaka K, Koma YI, Nishihara M, Tanaka H, Nakamizo S, Nagashima H, Maeyama M, Fujita Y, Yokozaki H, Hirose T, Kohmura E. Tumor-associated macrophage related interleukin-6 in cerebrospinal fluid as a prognostic marker for glioblastoma. J Clin Neurosci. 2019 Oct;68:281-289. doi: 10.1016/j.jocn.2019.07.020. Epub 2019 Jul 18.
PubMed 31327593Miller AM, Shah RH, Pentsova EI, Pourmaleki M, Briggs S, Distefano N, Zheng Y, Skakodub A, Mehta SA, Campos C, Hsieh WY, Selcuklu SD, Ling L, Meng F, Jing X, Samoila A, Bale TA, Tsui DWY, Grommes C, Viale A, Souweidane MM, Tabar V, Brennan CW, Reiner AS, Rosenblum M, Panageas KS, DeAngelis LM, Young RJ, Berger MF, Mellinghoff IK. Tracking tumour evolution in glioma through liquid biopsies of cerebrospinal fluid. Nature. 2019 Jan;565(7741):654-658. doi: 10.1038/s41586-019-0882-3. Epub 2019 Jan 23.
PubMed 30675060Carrano A, Zarco N, Phillipps J, Lara-Velazquez M, Suarez-Meade P, Norton ES, Chaichana KL, Quinones-Hinojosa A, Asmann YW, Guerrero-Cazares H. Human Cerebrospinal Fluid Modulates Pathways Promoting Glioblastoma Malignancy. Front Oncol. 2021 Mar 4;11:624145. doi: 10.3389/fonc.2021.624145. eCollection 2021.
PubMed 33747938
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile
- ClinicalTrials.gov ID
- NCT06845020
- Acronym / sponsor ID
- T05-273-1324-4794-19-00
- Conditions
- Glioblastoma, Glioblastoma WHO Grade IV, Glioblastoma (GBM), Glioblastoma Multiforme of the Brain, Glioblastoma, Adult
- Keywords
- Glioblastoma, Cerebrospinal fluid, CSF, GBM, Proteomics, Biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Univeridad Autonoma de GuadalajaraUniversity, hospital or other
- Collaborators
- Mayo Clinic, Hospital Valentin Gomez Farias
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 25 Feb 2025 (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 identify proteins that can be found in the cerebrospinal fluid (CSF) of patients with grade IV brain tumors, specifically glioblastomas, and correlate these proteins with progression free survival, overall survival and performance status (functionality). All participants with high probability of glioblastoma will initially be included, final inclusion will be dependent on the definitive histopathological diagnosis of the tumor.
The main question is:
Can the researchers identify a proteomic profile in CSF from study participants with glioblastoma in association with a longer progression free survival? Participants will undergo the following procedures, that do not deviate from normal standard diagnostic care.
- Lumbar puncture to obtain CSF.
- Blood draw.
- Trans-surgical tissue sample of the brain tumor. Additionally participants will be planned for follow up appointments every 3 months following the first 12 months after the surgical tumor resection.
Detailed description
To successfully complete the study the following procedures will be implemented after obtaining informed consent:
- Serum blood sample acquisition and storage
- CSF sample acquisition Of all subjects included in the study a CSF sample will be taken. The sampling will be pre-surgical by lumbar puncture. Before the lumbar puncture all patients will undergo brain imaging (CT or MRI), as well as an fundoscopic exam and a blood draw. Through patient history and clinical examination other neurological pathology is discarded (neurological focalization, altered mental status, recent seizures or any other previous or recent neurological pathology). Patients with lumbar puncture contraindications as sampling method will undergo trans-surgical sampling, as initial procedure performed during surgery to avoid contamination. All sampling must be taken before any radio- and/or chemotherapy.
- Storage of sampled CSF The CSF sample obtained will be minimally 3 mL (3 tubes of 1 mL), in sterile tubes without any type of additives. The sample will be stored at -80 °C.
- Tumour tissue acquisition and storage Of all subjects included in the study, tumour tissue samples will be obtained from the central zone, posteriorly molecular analysis and identification of coding genes for significant proteins in CSF will be performed with MALDI-TOF.
After obtaining the patient background information and the tissue samples (CSF, tumour and serum) genetic and histological testing will be performed to obtain glioblastoma diagnosis, following current guidelines, the next parameters must be present for definitive glioblastoma diagnosis, and thus inclusion in the study:
- IDH-Wildtype diffuse and astrocytic glioma in adults
+ microvascular proliferation or necrosis OR + TERT promotor mutation OR + EFGR gene amplification OR + +7/-10 chromosome copy number changes. When definitive diagnosis is obtained and inclusion in this study is confirmed there will be programmed follow-up visits at 3, 6, 9 and 12 months, where a previously designed questionnaire similar to the admission questionnaire will be performed to specify patient evolution, and functionality current adjuvant treatment, additionally a full physical exam including neurological exam will be performed, with a radiological imaging study (CT or MRI). In case of decease, this will be closely registered by contacting the patient or family one week before the follow-up appointment to confirm the appointment, in case of deceasement date and cause must be registered.
Statistical Analysis:
For the descriptive phase of the statistical analysis, it is intended to use the mean and standard deviation for the variables with parametric distribution and the median with Interquartile range for the variables with non-parametric distribution. Qualitative variables such as protein identification will be reported in frequencies and percentages. The inferential phase includes the creation of contingency tables and chi square. For the analysis of progression-free survival and overall survival, Kaplan Meier curves will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with definitive diagnosis of glioblastoma | – | –The cohort includes patients with a histopathological diagnosis of glioblastoma, defined by the 2021 guidelines: IDH-Wildtype diffuse and astrocytic glioma in adults + microvascular proliferation or necrosis OR + TERT promotor mutation OR + EFGR gene amplification OR + +7/-10 chromosome copy number changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population includes patients who arrive at the Hospital Regional 'Dr. Valentin Gomez Farias' ISSSTE, who have a high probability of glioblastoma diagnosis, based on clinical presentation and imaging. Additionally the population includes 5 patients whose samples and information has already been stored at the Mayo Clinic Florida.
Key inclusion criteria (3 listed)
- Patients with confirmed diagnosis of glioblastoma (histopathological and molecular).
- Patients who voluntarily accept participation in this study.
- Patients aged 18 or older.
Key exclusion criteria (4 listed)
- Patients who cannot be followed up at the Regional Hospital 'Dr. Valentin Gomez Farias' ISSSTE.
- Contamination of the required sample (CSF, serum, tumor).
- Patients with whom no sampling was obtained or subjects with incomplete background information.
- Patients who decide to withdraw participation from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Measured at 3, 6, 9, and 12 months, after participant recruitment.
The length of time the participants are still alive after tumor resection (initial recruitment date), including disease progression.
2 secondary outcomes
Progression free survival
Time frame: Measured at 3, 6, 9, and 12 months, after participant recruitment.
Performance status
Time frame: Measured at baseline, 3, 6, 9, and 12 months, after participant recruitment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 33735443Schmid D, Warnken U, Latzer P, Hoffmann DC, Roth J, Kutschmann S, Jaschonek H, Rubmann P, Foltyn M, Vollmuth P, Winkler F, Seliger C, Felix M, Sahm F, Haas J, Reuss D, Bendszus M, Wildemann B, von Deimling A, Wick W, Kessler T. Diagnostic biomarkers from proteomic characterization of cerebrospinal fluid in patients with brain malignancies. J Neurochem. 2021 Jul;158(2):522-538. doi: 10.1111/jnc.15350. Epub 2021 Apr 9.
- Background: PubMed 19011622Skog J, Wurdinger T, van Rijn S, Meijer DH, Gainche L, Sena-Esteves M, Curry WT Jr, Carter BS, Krichevsky AM, Breakefield XO. Glioblastoma microvesicles transport RNA and proteins that promote tumour growth and provide diagnostic biomarkers. Nat Cell Biol. 2008 Dec;10(12):1470-6. doi: 10.1038/ncb1800. Epub 2008 Nov 16.
- Background: PubMed 19674866Schuhmann MU, Zucht HD, Nassimi R, Heine G, Schneekloth CG, Stuerenburg HJ, Selle H. Peptide screening of cerebrospinal fluid in patients with glioblastoma multiforme. Eur J Surg Oncol. 2010 Feb;36(2):201-7. doi: 10.1016/j.ejso.2009.07.010. Epub 2009 Aug 11.
- Background: PubMed 25115191Jayaram S, Gupta MK, Polisetty RV, Cho WC, Sirdeshmukh R. Towards developing biomarkers for glioblastoma multiforme: a proteomics view. Expert Rev Proteomics. 2014 Oct;11(5):621-39. doi: 10.1586/14789450.2014.939634. Epub 2014 Aug 13.
- Background: PubMed 32628487Kohata T, Ito S, Masuda T, Furuta T, Nakada M, Ohtsuki S. Laminin Subunit Alpha-4 and Osteopontin Are Glioblastoma-Selective Secreted Proteins That Are Increased in the Cerebrospinal Fluid of Glioblastoma Patients. J Proteome Res. 2020 Aug 7;19(8):3542-3553. doi: 10.1021/acs.jproteome.0c00415. Epub 2020 Jul 16.
- Background: PubMed 31327593Hori T, Sasayama T, Tanaka K, Koma YI, Nishihara M, Tanaka H, Nakamizo S, Nagashima H, Maeyama M, Fujita Y, Yokozaki H, Hirose T, Kohmura E. Tumor-associated macrophage related interleukin-6 in cerebrospinal fluid as a prognostic marker for glioblastoma. J Clin Neurosci. 2019 Oct;68:281-289. doi: 10.1016/j.jocn.2019.07.020. Epub 2019 Jul 18.
- Background: PubMed 30675060Miller AM, Shah RH, Pentsova EI, Pourmaleki M, Briggs S, Distefano N, Zheng Y, Skakodub A, Mehta SA, Campos C, Hsieh WY, Selcuklu SD, Ling L, Meng F, Jing X, Samoila A, Bale TA, Tsui DWY, Grommes C, Viale A, Souweidane MM, Tabar V, Brennan CW, Reiner AS, Rosenblum M, Panageas KS, DeAngelis LM, Young RJ, Berger MF, Mellinghoff IK. Tracking tumour evolution in glioma through liquid biopsies of cerebrospinal fluid. Nature. 2019 Jan;565(7741):654-658. doi: 10.1038/s41586-019-0882-3. Epub 2019 Jan 23.
- Background: PubMed 33747938Carrano A, Zarco N, Phillipps J, Lara-Velazquez M, Suarez-Meade P, Norton ES, Chaichana KL, Quinones-Hinojosa A, Asmann YW, Guerrero-Cazares H. Human Cerebrospinal Fluid Modulates Pathways Promoting Glioblastoma Malignancy. Front Oncol. 2021 Mar 4;11:624145. doi: 10.3389/fonc.2021.624145. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
RecruitingPhase 2
Tamoxifen Versus Etoposide After First Recurrence in GBM Patients
Glioblastoma Multiforme
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.
Maria Guadalupe Zavala Cerna, MD, PhD principal investigator
Universidad Autónoma de Guadalajara
Hugo Guerrero Cazares, MD, PhD study chair
Mayo Clinic Jacksonville, Florida.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Glioblastoma WHO Grade IV, run by Univeridad Autonoma de Guadalajara.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Guadalupe Zavala Cerna, MD, PhD (+523336488824 ext. 33125, maria.cerna@edu.uag.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Measured at 3, 6, 9, and 12 months, after participant recruitment.). 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 NCT06845020, which also lists 8 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 25 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.