NCT06620926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
811

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

September 28, 2024

Last Update Submit

October 25, 2024

Conditions

Keywords

chemotherapysurvivalAstrocytomaWild IDH

Outcome Measures

Primary Outcomes (1)

  • The 2-year relative survival and 2-year observed survival of grade II/III astrocytoma with IDH mutation

    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

    Jan, 2018 till Dec, 2020

Study Arms (2)

Patients having astrocytoma with IDH mutant-type

Other: IDH mutant-type

Patients having astrocytoma with IDH wild-type

Other: IDH wild-type

Interventions

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

Patients having astrocytoma with IDH mutant-type

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

Patients having astrocytoma with IDH wild-type

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Astrocytoma

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Asmaa Ellaithy, MD

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident physician of gastroenterology

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 1, 2024

Study Start

January 1, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2021

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations