NCT05202626

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

January 9, 2022

Last Update Submit

October 13, 2023

Conditions

Keywords

Artificial IntelligenceClassificationNasopharyngeal CarcinomaNasopharyngoscopeImage-Guided Biopsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Accuray

    three months

Other Outcomes (1)

  • Statistical significance

    Three years

Study Arms (5)

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.

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.

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.

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.

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.

Diagnostic Test: Nasopharyngeal Endoscopy image-guided Biopsy

Interventions

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.

Fujian Provincial Cancer HospitalGuangdong Provincial People's HospitalHainan Provincial People's HospitalNanfang Hospital, Southern Medical UniversitySun Yat-Sen University Cancer Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Hainan Provincial People's Hospital

Haikou, Hainan, 570311, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33393666BACKGROUND
  • 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 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

For each participant exhibiting suspicious lesions during a nasopharyngeal endoscopy examination, the attending physician will determine the appropriate biopsy strategy based on the specific conditions of the lesion. The physician may opt for a single biopsy, taking a sample directly from within the lesion, or multiple biopsies, which would include one sample from inside the lesion, another from 5-8 mm outside the lesion, and a third from 8-10 mm outside the lesion. This decision will be grounded in clinical judgment and a comprehensive consideration of optimal diagnostic outcomes and patient safety.

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Yali Zang, ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 21, 2022

Study Start

December 1, 2021

Primary Completion

October 30, 2023

Study Completion

June 28, 2025

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations