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OpenTrials
Completed

NCT Number: NCT06620926

Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDH mutant-type

Other

The first arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy.

IDH wild-type

Other

The second arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy.

Primary outcomes

  1. 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

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

    Time frame: Jan, 2018 till Dec, 2020

Sponsors and collaborators

Lead sponsor

asmaa salama ibrahim

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 1, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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