Clinical trial NCT06620926: Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma
Official title: Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astrocytoma
Astrocytic Tumors
Astrocytoma of Brain
Keywords: chemotherapy
survival
Astrocytoma
Wild IDH
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 811
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* unknown survival time
* patients with unknown age
* death certificate only and autopsy only cases

Primary outcomes:
measure: The 2-year relative survival and 2-year observed survival of grade II/III astrocytoma with IDH mutation
timeFrame: from Jan, 2018 till Dec, 2020
Secondary outcomes:
measure: The 2-year relative survival of different treatment with modalities chemo(radio)therapy among both groups: IDH wild type and IDH mutant type astrocytoma
timeFrame: Jan, 2018 till Dec, 2020
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Asmaa Ellaithy, MD
role: PRINCIPAL_INVESTIGATOR
References: