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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05202626
Other study ID # CASMI002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date June 28, 2025

Study information

Verified date October 2023
Source Chinese Academy of Sciences
Contact Di Dong, Ph.D
Phone +86 010-82618465
Email di.dong@ia.ac.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 28, 2025
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Nasopharyngeal Endoscopy image-guided Biopsy
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.

Locations

Country Name City State
China Fujian Provincial Cancer Hospital Fuzhou Fujian
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong
China Hainan Provincial People's Hospital Haikou Hainan

Sponsors (6)

Lead Sponsor Collaborator
Chinese Academy of Sciences Fujian Cancer Hospital, Guangdong Provincial People's Hospital, Hainan People's Hospital, Nanfang Hospital, Southern Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Li 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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Statistical significance Statistical significance (P value) of DFS (time from diagnosis to disease progression or death from any cause) in nasopharyngeal carcinoma patients between high-risk and low-risk group identified by deep learning-based model. Three years
Primary Aera under the receiver operating characteristic curve (AUC) AUC of an deep learning-based model in discriminating nasopharyngeal carcinoma from bengin lesion. three months
Secondary 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). three months
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