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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06032767
Enrollment
480
Registered
2023-09-13
Start date
2023-08-14
Completion date
2024-12-30
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma, Oral Mucositis

Keywords

Nasopharyngeal Carcinoma, Oral Mucositis, deep learning

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.

Interventions

patients initially diagnosed with nasopharyngeal carcinoma treated with IMRT

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
RTOG/EROTC Acute Radiation Reaction Scoring Standardthrough radiation therapy, an average of 7 weeksToxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists

Countries

China

Contacts

Primary ContactFang-Yun Xie, M.D.
xiefy@sysucc.org.cn+8613902205880
Backup ContactPu-Yun OuYang, M.D.
ouyangpy@sysucc.org.cn+8618565382769

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026