AstrocytomaNCT06620926
Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma
An observational study of Astrocytoma and Astrocytic Tumors, run by asmaa salama ibrahim at 1 site in Egypt.
Trial summary
This study looked at a type of brain tumor called astrocytoma and how specific genetic changes like IDH mutations affect patients outcomes. Recent studies found that people with IDH-mutated astrocytomas tend to live longer and have better survival rates compared to those without these mutations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Astrocytoma, Astrocytic Tumors, Astrocytoma of Brain
- What is being tested?
- IDH mutant-type and IDH wild-type
- How many people
- 811 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with grade II/III astrocytoma with malignant behavior. The investigators sub-grouped the data according to the IDH mutation type into two groups: IDH wild-type and IDH-mutant type with further stratification according to the treatment modalities the patients received: adjuvant chemotherapy, adjuvant radiotherapy and adjuvant chemoradiotherapy; following any surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)
Who may be able to join
- Patients were selected only if they had astrocytoma with malignant behavior
- Grade II-III astrocytoma
- First primary tumor with sequence 0 or 1
- Had surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)
Who cannot join
- unknown survival time
- patients with unknown age
- death certificate only and autopsy only cases
Trial locations and contacts
1 site in 1 country.
About this study
This study looked at a type of brain tumor called astrocytoma and how specific genetic changes like IDH mutations affect patients outcomes. Recent studies found that people with IDH-mutated astrocytomas tend to live longer and have better survival rates compared to those without these mutations. One reason for this is that IDH-mutated tumors usually grow more slowly and are less aggressive. These findings suggest that testing for IDH mutations could help doctors make more personalized treatment plans for patients, which may lead to better results. However, larger studies are needed to confirm these observations. the investigators used the Surveillance, Epidemiology and End Results (SEER) database to obtain the data of 811 patients with grade II/III astrocytoma. The data are publicly available and no consent or ethical approval is needed for this study. The clinicopathological data of patients, including the age, gender, race, IDH status (mutant/wild), astrocytoma type (diffuse/anaplastic), surgery (tumor destruction, Local excision, partial, radical, total gross resection, Surgery), radiation (Beam radiation, Radioactive implants including brachytherapy, Radioisotopes, Combination of beam with implants or isotopes, Radiation, method or source not specified), chemotherapy, vital status, and survival months, were extracted. Patients were sub-grouped according to the IDH type into IDH mutant-type and wild-type. with further stratification according to the treatment modality into three groups: adjuvant chemotherapy, adjuvant radiotherapy, and combined adjuvant chemoradiotherapy. The Observed survival and cause-specific survival were calculated using SEER*stat software version 8.4.3 and SPSS version 25 was used for survival analysis. Significance was achieved at 0.05.
- Conditions
- Astrocytoma, Astrocytic Tumors, Astrocytoma of Brain
- Being tested
- IDH mutant-type, IDH wild-type
- Keywords
- chemotherapy, survival, Astrocytoma, Wild IDH
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDH mutant-typeOther
The first arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy.
IDH wild-typeOther
The second arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients having astrocytoma with IDH mutant-type | Not described Receives: Other: IDH mutant-type | |
| Patients having astrocytoma with IDH wild-type | Not described Receives: Other: IDH wild-type |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 2-year relative survival and 2-year observed survival of grade II/III astrocytoma with IDH mutation
Measured: from Jan, 2018 till Dec, 2020
Secondary outcomes (1)
The 2-year relative survival of different treatment with modalities chemo(radio)therapy among both groups: IDH wild type and IDH mutant type astrocytoma
Measured: Jan, 2018 till Dec, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 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 AstrocytomaStudies 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
- Retrospective
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- asmaa salama ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, asmaa salama ibrahim, Suez Canal University
- Investigators
- Asmaa Ellaithy, MD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620926
- Sponsor's protocol ID
- A1997
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data is publicly available through SEER database
Publications
Hamad M, Ali MA, Hamouda E, Hamouda H, Ali N, Al-Shaikh B, Ellaithy A. Impact of IDH mutation and adjuvant chemo(radio)therapy on survival outcome in grade II/III astrocytoma: a retrospective cohort study based on SEER database. Ann Med Surg (Lond). 2025 Mar 20;87(4):1846-1851. doi: 10.1097/MS9.0000000000003172. eCollection 2025 Apr.
PubMed 40212132
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma
- ClinicalTrials.gov ID
- NCT06620926
- Acronym / sponsor ID
- A1997
- Conditions
- Astrocytoma, Astrocytic Tumors, Astrocytoma of Brain
- Keywords
- chemotherapy, survival, Astrocytoma, Wild IDH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- asmaa salama ibrahimUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Oct 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.
This study looked at a type of brain tumor called astrocytoma and how specific genetic changes like IDH mutations affect patients outcomes. Recent studies found that people with IDH-mutated astrocytomas tend to live longer and have better survival rates compared to those without these mutations. One reason for this is that IDH-mutated tumors usually grow more slowly and are less aggressive. These findings suggest that testing for IDH mutations could help doctors make more personalized treatment plans for patients, which may lead to better results. However, larger studies are needed to confirm these observations. the investigators used the Surveillance, Epidemiology and End Results (SEER) database to obtain the data of 811 patients with grade II/III astrocytoma. The data are publicly available and no consent or ethical approval is needed for this study. The clinicopathological data of patients, including the age, gender, race, IDH status (mutant/wild), astrocytoma type (diffuse/anaplastic), surgery (tumor destruction, Local excision, partial, radical, total gross resection, Surgery), radiation (Beam radiation, Radioactive implants including brachytherapy, Radioisotopes, Combination of beam with implants or isotopes, Radiation, method or source not specified), chemotherapy, vital status, and survival months, were extracted. Patients were sub-grouped according to the IDH type into IDH mutant-type and wild-type. with further stratification according to the treatment modality into three groups: adjuvant chemotherapy, adjuvant radiotherapy, and combined adjuvant chemoradiotherapy. The Observed survival and cause-specific survival were calculated using SEER*stat software version 8.4.3 and SPSS version 25 was used for survival analysis. Significance was achieved at 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients having astrocytoma with IDH mutant-type | – | Other: IDH mutant-type |
| Patients having astrocytoma with IDH wild-type | – | Other: IDH wild-type |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with grade II/III astrocytoma with malignant behavior. The investigators sub-grouped the data according to the IDH mutation type into two groups: IDH wild-type and IDH-mutant type with further stratification according to the treatment modalities the patients received: adjuvant chemotherapy, adjuvant radiotherapy and adjuvant chemoradiotherapy; following any surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)
Key inclusion criteria (4 listed)
- Patients were selected only if they had astrocytoma with malignant behavior
- Grade II-III astrocytoma
- First primary tumor with sequence 0 or 1
- Had surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)
Key exclusion criteria (3 listed)
- unknown survival time
- patients with unknown age
- death certificate only and autopsy only cases
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 |
|---|---|---|
| IDH mutant-typeThe first arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy. | Other | Patients having astrocytoma with IDH mutant-type |
| IDH wild-typeThe second arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy. | Other | Patients having astrocytoma with IDH wild-type |
Primary outcome
The 2-year relative survival and 2-year observed survival of grade II/III astrocytoma with IDH mutation
Time frame: from Jan, 2018 till Dec, 2020
1 secondary outcome
The 2-year relative survival of different treatment with modalities chemo(radio)therapy among both groups: IDH wild type and IDH mutant type astrocytoma
Time frame: Jan, 2018 till Dec, 2020
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 29 Oct 2024.
- Derived from this study: PubMed 40212132Hamad M, Ali MA, Hamouda E, Hamouda H, Ali N, Al-Shaikh B, Ellaithy A. Impact of IDH mutation and adjuvant chemo(radio)therapy on survival outcome in grade II/III astrocytoma: a retrospective cohort study based on SEER database. Ann Med Surg (Lond). 2025 Mar 20;87(4):1846-1851. doi: 10.1097/MS9.0000000000003172. eCollection 2025 Apr.
- Individual participant dataSharing planned: Undecided. The data is publicly available through SEER database
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Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
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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.
Asmaa Ellaithy, MD principal investigator
Suez Canal 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 Astrocytoma and Astrocytic Tumors, run by asmaa salama ibrahim 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 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 29 Oct 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?
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?
The 2-year relative survival and 2-year observed survival of grade II/III astrocytoma with IDH mutation (time frame: from Jan, 2018 till Dec, 2020). 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 NCT06620926, 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 29 Oct 2024.