Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06032767

Collaborator

(none)

480

Enrollment

15.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to apply the CNN-based DL method to extract the three-dimensional spatial information of IMRT dose distribution to predict the occurrence probability of serious radiotherapy and chemotherapy induced oral mucositis(SRCOM), and compare with a model based on dosimetry, NTCP or doseomics to improve the prediction accuracy of SRCOM, thus guiding the clinical planning design, reducing the occurrence probability of OM, and may have the potential value of preventing serious complications and improving the quality of life in patients with nasopharyngeal carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Oral Mucositis	Other: observational group

Study Design

Study Type:

Observational

Anticipated Enrollment :

480 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning

Anticipated Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Outcome Measures

Primary Outcome Measures

RTOG/EROTC Acute Radiation Reaction Scoring Standard [through radiation therapy, an average of 7 weeks]
Toxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Initial diagnosis, pathological histological diagnosis, the pathological type is non-keratotic carcinoma (according to the WHO pathological classification).
Initial intensity-modulated radiotherapy (Intensity modulated radiation therapy, IMRT).
No previous radiotherapy was received.

Exclusion Criteria:

Patients with recurrent nasopharyngeal carcinoma.
Radiotherapy plan cannot be obtained.
Previous history of malignancy; previous radiotherapy.
The primary lesion and cervical metastatic lesions have received surgical treatment (except for diagnostic treatment).