NCT05627310

Brief Summary

Develop a deep learning algorithm via nasal endoscopic images from eight NPC treatment centerto detect and screen nasopharyngeal carcinoma(NPC).

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
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

July 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

July 11, 2022

Last Update Submit

November 23, 2022

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinomadeep learningtumor screening

Outcome Measures

Primary Outcomes (1)

  • Area under the receiver operating characteristic curve of the deep learning algorithm

    The investigators will calculate the area under the receiver operating characteristic curve of deep learning algorithm and compare this index between deep learning system and human doctors.

    baseline

Secondary Outcomes (2)

  • Sensitivity of the deep learning system

    baseline

  • Specificity of the deep learning system

    baseline

Study Arms (3)

Training Cohort

Nasopharyngeal endoscopic images collected from 8 hospitals all over China

Validation Cohort

Nasopharyngeal endoscopic images collected from 8 hospitals all over China

Other: Diagnostic

Testing Cohort

Nasopharyngeal endoscopic images prospectively collected from 8 hospitals all over China

Other: Diagnostic

Interventions

DiagnosticOTHER

Training dataset was used to train the deep learning model, which was validated and tested by external dataset.

Testing CohortValidation Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nasopharyngeal endoscopic images were collected from 8 hospital in NPC epidemic area all over China.

You may qualify if:

  • The quality of endoscopic images should clinical acceptable.
  • Patients were diagnosed with biopsy(NPC, benign hyperplasia). Control corhort(normal nasopharynx) don't require bispsy result.

You may not qualify if:

  • images with spots from lens flares or stains, and overexposure were excluded from further analysis.
  • image can not expose most part of lesion clearly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Quan Zhou First Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

RECRUITING

The People' s Hospital of Jiangmen

Jiangmen, Guangdong, China

RECRUITING

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

The People' s Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Eye&ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

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

Study Officials

  • Hongmeng Yu, MD PhD

    Eye&ENT Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Xuan Shi, MD PhD

CONTACT

+8618952373378syxent@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

November 25, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

November 25, 2022

Record last verified: 2022-11

Locations

CN(8)