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

NCT ID: NCT06032767

Last Updated: 2024-01-05

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

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-14

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma Oral Mucositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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observational group

patients initially diagnosed with nasopharyngeal carcinoma treated with IMRT

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Fang-Yun Xie

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang-Yun Xie, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang-Yun Xie, M.D.

Role: CONTACT

+8613902205880

Pu-Yun OuYang, M.D.

Role: CONTACT

+8618565382769

Facility Contacts

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Fang-Yun Xie, professor

Role: primary

+86-20-87342926

References

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Wolden SL, Chen WC, Pfister DG, Kraus DH, Berry SL, Zelefsky MJ. Intensity-modulated radiation therapy (IMRT) for nasopharynx cancer: update of the Memorial Sloan-Kettering experience. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):57-62. doi: 10.1016/j.ijrobp.2005.03.057. Epub 2005 Jun 2.

Reference Type RESULT
PMID: 15936155 (View on PubMed)

Li K, Yang L, Hu QY, Chen XZ, Chen M, Chen Y. Oral Mucosa Dose Parameters Predicting Grade >/=3 Acute Toxicity in Locally Advanced Nasopharyngeal Carcinoma Patients Treated With Concurrent Intensity-Modulated Radiation Therapy and Chemotherapy: An Independent Validation Study Comparing Oral Cavity versus Mucosal Surface Contouring Techniques. Transl Oncol. 2017 Oct;10(5):752-759. doi: 10.1016/j.tranon.2017.06.011. Epub 2017 Jul 21.

Reference Type RESULT
PMID: 28738294 (View on PubMed)

Elad S, Yarom N, Zadik Y, Kuten-Shorrer M, Sonis ST. The broadening scope of oral mucositis and oral ulcerative mucosal toxicities of anticancer therapies. CA Cancer J Clin. 2022 Jan;72(1):57-77. doi: 10.3322/caac.21704. Epub 2021 Oct 29.

Reference Type RESULT
PMID: 34714553 (View on PubMed)

Soutome S, Yanamoto S, Nishii M, Kojima Y, Hasegawa T, Funahara M, Akashi M, Saito T, Umeda M. Risk factors for severe radiation-induced oral mucositis in patients with oral cancer. J Dent Sci. 2021 Oct;16(4):1241-1246. doi: 10.1016/j.jds.2021.01.009. Epub 2021 Feb 9.

Reference Type RESULT
PMID: 34484592 (View on PubMed)

Li PJ, Li KX, Jin T, Lin HM, Fang JB, Yang SY, Shen W, Chen J, Zhang J, Chen XZ, Chen M, Chen YY. Predictive Model and Precaution for Oral Mucositis During Chemo-Radiotherapy in Nasopharyngeal Carcinoma Patients. Front Oncol. 2020 Nov 5;10:596822. doi: 10.3389/fonc.2020.596822. eCollection 2020.

Reference Type RESULT
PMID: 33224892 (View on PubMed)

Gabrys HS, Buettner F, Sterzing F, Hauswald H, Bangert M. Design and Selection of Machine Learning Methods Using Radiomics and Dosiomics for Normal Tissue Complication Probability Modeling of Xerostomia. Front Oncol. 2018 Mar 5;8:35. doi: 10.3389/fonc.2018.00035. eCollection 2018.

Reference Type RESULT
PMID: 29556480 (View on PubMed)

Zhen X, Chen J, Zhong Z, Hrycushko B, Zhou L, Jiang S, Albuquerque K, Gu X. Deep convolutional neural network with transfer learning for rectum toxicity prediction in cervical cancer radiotherapy: a feasibility study. Phys Med Biol. 2017 Oct 12;62(21):8246-8263. doi: 10.1088/1361-6560/aa8d09.

Reference Type RESULT
PMID: 28914611 (View on PubMed)

Ibragimov B, Toesca D, Chang D, Yuan Y, Koong A, Xing L. Development of deep neural network for individualized hepatobiliary toxicity prediction after liver SBRT. Med Phys. 2018 Oct;45(10):4763-4774. doi: 10.1002/mp.13122. Epub 2018 Sep 10.

Reference Type RESULT
PMID: 30098025 (View on PubMed)

Other Identifiers

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B2022-420-Y01

Identifier Type: -

Identifier Source: org_study_id

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