Nasopharyngeal CarcinomaNCT06032767
Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning
An observational study of Nasopharyngeal Carcinoma and Oral Mucositis, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma, Oral Mucositis
- What is being tested?
- observational group
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary-treated NPC patients undergoing IMRT
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fang-Yun Xie, professor, +86-20-87342926, xiefy@sysucc.org.cn
About this study
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.
- Conditions
- Nasopharyngeal Carcinoma, Oral Mucositis
- Being tested
- observational group
- Keywords
- Nasopharyngeal Carcinoma, Oral Mucositis, deep learning
- Medical subject headings
- Nasopharyngeal Carcinoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational groupOther
patients initially diagnosed with nasopharyngeal carcinoma treated with IMRT
What is being measured
The primary outcome is the main question the study is designed to answer.
RTOG/EROTC Acute Radiation Reaction Scoring Standard
Toxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists
Measured: through radiation therapy, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start14 Aug 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
- Investigators
- Fang-Yun Xie, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032767
- Sponsor's protocol ID
- B2022-420-Y01
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15936155Li 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.
PubMed 28738294Elad 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.
PubMed 34714553Soutome 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.
PubMed 34484592Li 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.
PubMed 33224892Gabrys 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.
PubMed 29556480Zhen 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.
PubMed 28914611Ibragimov 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.
PubMed 30098025
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning
- ClinicalTrials.gov ID
- NCT06032767
- Acronym / sponsor ID
- B2022-420-Y01
- Conditions
- Nasopharyngeal Carcinoma, Oral Mucositis
- Keywords
- Nasopharyngeal Carcinoma, Oral Mucositis, deep learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary-treated NPC patients undergoing IMRT
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational grouppatients initially diagnosed with nasopharyngeal carcinoma treated with IMRT | Other | – |
Primary outcome
RTOG/EROTC Acute Radiation Reaction Scoring Standard
Time frame: through radiation therapy, an average of 7 weeks
Toxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Results publication: PubMed 15936155Wolden 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.
- Results publication: PubMed 28738294Li 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.
- Results publication: PubMed 34714553Elad 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.
- Results publication: PubMed 34484592Soutome 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.
- Results publication: PubMed 33224892Li 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.
- Results publication: PubMed 29556480Gabrys 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.
- Results publication: PubMed 28914611Zhen 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.
- Results publication: PubMed 30098025Ibragimov 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.
- Individual participant dataSharing planned: Undecided
Related trials for Nasopharyngeal Carcinoma
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang-Yun Xie, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Oral Mucositis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang-Yun Xie, M.D. (+8613902205880, xiefy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RTOG/EROTC Acute Radiation Reaction Scoring Standard (time frame: through radiation therapy, an average of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06032767, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.