High Grade AstrocytomaNCT06214689
IDH1 and OCT4 in High Grade Astrocytoma
An observational study of High Grade Astrocytoma, run by Assiut University at 1 site in Egypt.
Trial summary
observation of IDH1 and OCT4 markers level and high grade astrocytoma patients prognosis after excision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Astrocytoma
- What is being tested?
- biomarkers analysis
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2024to Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with high grade astrocytic glioma , more than 18 years old and fit for surgery that will be admitted in the department of neurosurgery in Assiut university hospital
Who may be able to join
- patients of high grade astrocytic glioma patients fit for surgery
Who cannot join
- patients of low grade glioma patients unfit for surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine of Assiut University
Asyut, 71525
Abdelrahman A Salama, resident, 01002796190, adhamsalama001@gmail.com
Mahmoud H Ragab, professor, 01004001789, Ragabm@gmail.com
About this study
Official title: IDH1 and OCT4 Markers as a Prognostic Factor in Clinical Outcome of High Grade Astrocytic Glioma
observation of IDH1 and OCT4 markers level and high grade astrocytoma patients prognosis after excision.
Read the detailed description
explore the relationship between prognosis and IDH1 and OCT4 biomarkers after high grade astrocytoma excision , according to progression free survival and overall survival , in prospective and retrospective samples.
- Conditions
- High Grade Astrocytoma
- Being tested
- biomarkers analysis
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkers analysisOther
IDH1 and OCT4 markers analysis of surgical specimens of high grade astrocytoma
What is being measured
The primary outcome is the main question the study is designed to answer.
IDH1 and OCT4 markers and their relation to postoperative prognosis of high grade astrocytoma patients
explore the relationship between prognosis (progression free and overall survival ) and biomarkers (IDH1 and OCT4 ) after excision of high grade astrocytoma
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startSep 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High Grade AstrocytomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ata Salama Swefy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214689
- Sponsor's protocol ID
- biomarkers in astrocytoma
- Status last verified
- Aug 2024
- First submitted
- 10 Jan 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
PubMed
Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.
PubMed 24842956Perry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0.
PubMed 26948349Sathornsumetee S, Rich JN, Reardon DA. Diagnosis and treatment of high-grade astrocytoma. Neurol Clin. 2007 Nov;25(4):1111-39, x. doi: 10.1016/j.ncl.2007.07.004.
PubMed 17964028
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDH1 and OCT4 Markers as a Prognostic Factor in Clinical Outcome of High Grade Astrocytic Glioma
- ClinicalTrials.gov ID
- NCT06214689
- Acronym / sponsor ID
- biomarkers in astrocytoma
- Conditions
- High Grade Astrocytoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 19 Jan 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.
observation of IDH1 and OCT4 markers level and high grade astrocytoma patients prognosis after excision.
Detailed description
explore the relationship between prognosis and IDH1 and OCT4 biomarkers after high grade astrocytoma excision , according to progression free survival and overall survival , in prospective and retrospective samples.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with high grade astrocytic glioma , more than 18 years old and fit for surgery that will be admitted in the department of neurosurgery in Assiut university hospital
Key inclusion criteria (1 listed)
- patients of high grade astrocytic glioma patients fit for surgery
Key exclusion criteria (1 listed)
- patients of low grade glioma patients unfit for surgery
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 |
|---|---|---|
| biomarkers analysisIDH1 and OCT4 markers analysis of surgical specimens of high grade astrocytoma | Other | – |
Primary outcome
IDH1 and OCT4 markers and their relation to postoperative prognosis of high grade astrocytoma patients
Time frame: baseline
explore the relationship between prognosis (progression free and overall survival ) and biomarkers (IDH1 and OCT4 ) after excision of high grade astrocytoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- BackgroundPubMed
- Results publication: PubMed 24842956Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.
- Results publication: PubMed 26948349Perry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0.
- Results publication: PubMed 17964028Sathornsumetee S, Rich JN, Reardon DA. Diagnosis and treatment of high-grade astrocytoma. Neurol Clin. 2007 Nov;25(4):1111-39, x. doi: 10.1016/j.ncl.2007.07.004.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Astrocytoma, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 6 Aug 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 Egypt. 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 Abdelrahman A Salama, resident (01002796190, adhamsalama001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IDH1 and OCT4 markers and their relation to postoperative prognosis of high grade astrocytoma patients (time frame: baseline). 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 NCT06214689, which also lists 4 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 6 Aug 2024.