Study on Radiogenomics Features Associated With Radiochemotherapy Sensitivity in Gliomas

NCT ID: NCT06454097

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2024-12-31

Brief Summary

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The MRI data were collected from patients with gliomas before surgery, 2 weeks before initiating radiochemotherapy, 1 month after completing the radiotherapy (for lower-grade gliomas, LGG), or 4 and 10 months after completing the radiochemotherapy (for high-grade gliomas, HGG). Radiochemotherapy sensitivity labels were constructed based on the MRI images obtained before and after radiochemotherapy, following the RANO criteria. Radiomics features were extracted from preoperative MRI images and combined with transcriptomic information obtained from tumor tissue sequencing. This process allowed the construction of a radiogenomics model capable of predicting the response of gliomas to radiochemotherapy.

In this prospective cohort study, we will recruit patients with gliomas who have undergone craniotomy and received postoperative radiotherapy or radiochemotherapy (in cases of LGG and HGG, respectively). MRI images of the same sequences will be collected at corresponding time points, and transcriptomic sequencing will be performed on tumor tissue obtained during surgery. The established model will be applied to predict radiochemotherapy sensitivity and compared with the 'true' radiochemotherapy sensitivity labels, which are constructed based on the RANO criteria, to evaluate the predictive performance of the model.

Detailed Description

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This trial aims to recruit 100 cases of LGG and 100 cases of HGG based on statistical calculations. MRI data, including T1-weighted, T2-weighted, T1 contrast-enhanced, and T2-Fluid Attenuated Inversion Recovery (FLAIR) sequences, will be collected before surgery, 2 weeks before initiating radiochemotherapy, 1 month after completing the radiotherapy (LGG), or 4 and 10 months after completing the radiochemotherapy (HGG).

The collected MRI images before and after radiochemotherapy will be used to assess changes in tumor volume. The RANO criteria will be employed to determine the tumor's sensitivity to radiochemotherapy: a complete response and partial response will be classified as sensitive, while stable disease and disease progression will be considered insensitive.

Radiomics features will be extracted using the open-source 'PyRadiomics' python package after performing image preprocessing and segmentation. Transcriptomic data will be obtained by conducting RNA sequencing analysis on tumor samples collected during surgery. Selected radiogenomic features will be incorporated into a pre-constructed machine learning model to predict the sensitivity of gliomas to radiochemotherapy. The model's performance will be evaluated using metrics such as classification accuracy (ACC), area under the receiver operating characteristic curve (AUC), positive predictive value (PPV), and negative predictive value (NPV).

Conditions

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Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Evaluate the response of patients with glioma to radiochemotherapy

The response of patients with glioma to radiochemotherapy will be assessed by the RANO criteria and the established radiogenomics-based artificial intellegent model.

Group Type OTHER

Assess the response glioma to radiochemotherapy using radiogenomics-based AI model

Intervention Type DIAGNOSTIC_TEST

Predict the radiochemotherapy sensitivity of patients with glioma using an established radiogenomics-based artificial intellegent mode

Interventions

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Assess the response glioma to radiochemotherapy using radiogenomics-based AI model

Predict the radiochemotherapy sensitivity of patients with glioma using an established radiogenomics-based artificial intellegent mode

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 or older
* Histologically confirmed glioma
* No history of other brain tumors or previous cranial surgeries
* No history of preoperative radiotherapy or chemotherapy
* Available preoperative, pre-radiotherapy(postoperatively), and post-radiotherapy magnetic resonance imaging (MRI) data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yinyan Wang, MD and PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yinyan Wang, MD and PhD

Role: CONTACT

+86 13581698953

Tao Jiang, MD and PhD

Role: CONTACT

+86 10 67021832

Facility Contacts

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Yinyan Wang, MD and PhD

Role: primary

+86 13581698953

Other Identifiers

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82072786

Identifier Type: -

Identifier Source: org_study_id

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