Nasopharyngeal CarcinomaNCT05202626
Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images
An observational study of Nasopharyngeal Carcinoma and Image-Guided Biopsy, run by Chinese Academy of Sciences at 5 sites in China.
Trial summary
Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Image-Guided Biopsy
- What is being tested?
- Nasopharyngeal Endoscopy image-guided Biopsy
- How many people
- 100 participants
- Where
- 5 sitesChina
- Study dates
- 1 Dec 2021to 28 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinican considered it necessary to perform an endoscopic image-guided biopsy.
Who may be able to join
- The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinicans considered it necessary to perform an biopsy.
- Hemilateral lesion with limited size.
Who cannot join
- Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.
Trial locations and contacts
5 sites in 1 country.
Yali Zang, ph.D contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Sufang Qiu
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510060
Zhongming Lu
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510060
Xiong Liu
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Linglong Tang, tangll@sysucc.org.cn
- Recruiting
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
Feng Chen, fenger0802@163.com
About this study
Official title: Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images：a Multi-center Prospective Study
Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.
Read the detailed description
Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.
- Conditions
- Nasopharyngeal Carcinoma, Image-Guided Biopsy
- Being tested
- Nasopharyngeal Endoscopy image-guided Biopsy
- Keywords
- Artificial Intelligence, Classification, Nasopharyngeal Carcinoma, Nasopharyngoscope, Image-Guided Biopsy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal Endoscopy image-guided BiopsyDiagnostic test
For each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous.
| Study group | Role | What they receive |
|---|---|---|
| Sun Yat-Sen University Cancer Center | The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Sun Yat-Sen University Cancer Center. The physicians in Sun Yat-Sen University Cancer Center consider it necessary to perform an endoscopic image-guided biopsy. Receives: Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy | |
| Guangdong Provincial People's Hospital | The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Guangdong Provincial People's Hospital. The physicians in Guangdong Provincial People's Hospital consider it necessary to perform an endoscopic image-guided biopsy. Receives: Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy | |
| Nanfang Hospital, Southern Medical University | The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Nanfang Hospital. The physicians in Nanfang Hospital consider it necessary to perform an endoscopic image-guided biopsy. Receives: Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy | |
| Fujian Provincial Cancer Hospital | The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Fujian Provincial Cancer Hospital. The physicians in Fujian Provincial Cancer Hospital consider it necessary to perform an endoscopic image-guided biopsy. Receives: Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy | |
| Hainan Provincial People's Hospital | The participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Hainan Provincial People's Hospital. The physicians in Hainan Provincial People's Hospital consider it necessary to perform an endoscopic image-guided biopsy. Receives: Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aera under the receiver operating characteristic curve (AUC)
AUC of an deep learning-based model in discriminating nasopharyngeal carcinoma from bengin lesion.
Measured: three months
Secondary outcomes (1)
Accuray
The agreement between the deep learning-based model and the histopathological diagnosis of the three biopsy specimens (inside the lesion, 5-8 mm outside the lesion, and 8-10 mm outside the lesion).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Sun Yat-sen University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Fujian Cancer Hospital, Hainan People's Hospital
- Responsible party
- Principal investigator, Di Dong, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202626
- Sponsor's protocol ID
- CASMI002
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zwakenberg MA, Halmos GB, Wedman J, van der Laan BFAM, Plaat BEC. Evaluating Laryngopharyngeal Tumor Extension Using Narrow Band Imaging Versus Conventional White Light Imaging. Laryngoscope. 2021 Jul;131(7):E2222-E2231. doi: 10.1002/lary.29361. Epub 2021 Jan 4.
PubMed 33393666Li C, Jing B, Ke L, Li B, Xia W, He C, Qian C, Zhao C, Mai H, Chen M, Cao K, Mo H, Guo L, Chen Q, Tang L, Qiu W, Yu Y, Liang H, Huang X, Liu G, Li W, Wang L, Sun R, Zou X, Guo S, Huang P, Luo D, Qiu F, Wu Y, Hua Y, Liu K, Lv S, Miao J, Xiang Y, Sun Y, Guo X, Lv X. Development and validation of an endoscopic images-based deep learning model for detection with nasopharyngeal malignancies. Cancer Commun (Lond). 2018 Sep 25;38(1):59. doi: 10.1186/s40880-018-0325-9.
PubMed 30253801
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images：a Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT05202626
- Acronym / sponsor ID
- CASMI002
- Conditions
- Nasopharyngeal Carcinoma, Image-Guided Biopsy
- Keywords
- Artificial Intelligence, Classification, Nasopharyngeal Carcinoma, Nasopharyngoscope, Image-Guided Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Sun Yat-sen University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Fujian Cancer Hospital, Hainan People's Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 21 Jan 2022 (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.
Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.
Detailed description
Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-Sen University Cancer Center | – | Diagnostic Test: Nasopharyngeal Endoscopy image-guided BiopsyThe participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Sun Yat-Sen University Cancer Center. The physicians in Sun Yat-Sen University Cancer Center consider it necessary to perform an endoscopic image-guided biopsy. |
| Guangdong Provincial People's Hospital | – | Diagnostic Test: Nasopharyngeal Endoscopy image-guided BiopsyThe participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Guangdong Provincial People's Hospital. The physicians in Guangdong Provincial People's Hospital consider it necessary to perform an endoscopic image-guided biopsy. |
| Nanfang Hospital, Southern Medical University | – | Diagnostic Test: Nasopharyngeal Endoscopy image-guided BiopsyThe participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Nanfang Hospital. The physicians in Nanfang Hospital consider it necessary to perform an endoscopic image-guided biopsy. |
| Fujian Provincial Cancer Hospital | – | Diagnostic Test: Nasopharyngeal Endoscopy image-guided BiopsyThe participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Fujian Provincial Cancer Hospital. The physicians in Fujian Provincial Cancer Hospital consider it necessary to perform an endoscopic image-guided biopsy. |
| Hainan Provincial People's Hospital | – | Diagnostic Test: Nasopharyngeal Endoscopy image-guided BiopsyThe participant who is found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy in Hainan Provincial People's Hospital. The physicians in Hainan Provincial People's Hospital consider it necessary to perform an endoscopic image-guided biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinican considered it necessary to perform an endoscopic image-guided biopsy.
Key inclusion criteria (2 listed)
- The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinicans considered it necessary to perform an biopsy.
- Hemilateral lesion with limited size.
Key exclusion criteria (1 listed)
- Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.
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 |
|---|---|---|
| Nasopharyngeal Endoscopy image-guided BiopsyFor each participant presenting with a suspicious nasopharyngeal lesion, the attending physician will assess the lesion and determine the appropriate biopsy approach. The physician may decide on multiple biopsies from the lesion area, including one sample from within the lesion itself, another from 5-8 mm outside the lesion, and a third from 8-10 mm beyond the lesion. Alternatively, a single biopsy may be deemed sufficient based on the clinical judgment. Each of these specimens will undergo pathological examination to confirm whether they are carcinomatous or non-carcinomatous. | Diagnostic test | Fujian Provincial Cancer Hospital, Guangdong Provincial People's Hospital, Hainan Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Sun Yat-Sen University Cancer Center |
Primary outcome
Aera under the receiver operating characteristic curve (AUC)
Time frame: three months
AUC of an deep learning-based model in discriminating nasopharyngeal carcinoma from bengin lesion.
1 secondary outcome
Accuray
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 33393666Zwakenberg MA, Halmos GB, Wedman J, van der Laan BFAM, Plaat BEC. Evaluating Laryngopharyngeal Tumor Extension Using Narrow Band Imaging Versus Conventional White Light Imaging. Laryngoscope. 2021 Jul;131(7):E2222-E2231. doi: 10.1002/lary.29361. Epub 2021 Jan 4.
- Results publication: PubMed 30253801Li C, Jing B, Ke L, Li B, Xia W, He C, Qian C, Zhao C, Mai H, Chen M, Cao K, Mo H, Guo L, Chen Q, Tang L, Qiu W, Yu Y, Liang H, Huang X, Liu G, Li W, Wang L, Sun R, Zou X, Guo S, Huang P, Luo D, Qiu F, Wu Y, Hua Y, Liu K, Lv S, Miao J, Xiang Y, Sun Y, Guo X, Lv X. Development and validation of an endoscopic images-based deep learning model for detection with nasopharyngeal malignancies. Cancer Commun (Lond). 2018 Sep 25;38(1):59. doi: 10.1186/s40880-018-0325-9.
- Individual participant dataSharing planned: Undecided
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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.
Yali Zang, ph.D contact
5 sites 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 Image-Guided Biopsy, run by Chinese Academy of Sciences at 5 sites 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 2 inclusion and 1 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Di Dong, Ph.D (+86 010-82618465, di.dong@ia.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aera under the receiver operating characteristic curve (AUC) (time frame: three months). 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 NCT05202626, which also lists 2 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 17 Oct 2023.