Impact of IDH Mutation and Adjuvant Chemo(radio)therapy o... | NCT06620926

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

NCT06620926

Sponsor

asmaa salama ibrahim

Status

Completed

Last Update Posted

Oct 29, 2024Actual

Enrollment

811Actual

Phase

Not provided

Conditions

Astrocytoma
Astrocytic Tumors
Astrocytoma of Brain

Interventions

IDH mutant-type
IDH wild-type

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Sep 28, 2024

First Submission Date that Met QC Criteria

Sep 28, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2024

Last Update Posted Date

Oct 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

811Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients having astrocytoma with IDH mutant-type			Other: IDH mutant-type
Patients having astrocytoma with IDH wild-type			Other: IDH wild-type

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asmaa Ellaithy, MD	Suez Canal University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suez Canal University		Ismailia			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40212132	Derived	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.

ID	Term
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal