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RecruitingNCT05202626Updated Oct 17, 2023

Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images

An observational study in Nasopharyngeal Carcinoma and Image-Guided Biopsy, sponsored by Chinese Academy of Sciences. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Chinese Academy of Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Dec 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Nasopharyngeal Carcinoma
  • Image-Guided Biopsy

Keywords

  • Artificial Intelligence
  • Classification
  • Nasopharyngeal Carcinoma
  • Nasopharyngoscope
  • Image-Guided Biopsy
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In context

Nasopharyngeal Carcinoma

683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 118 observational studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinicans considered it necessary to perform an .
  • Hemilateral lesion with limited size.

Exclusion criteria

Exclusion Criteria:

  • Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testNasopharyngeal 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.

06

What researchers measure

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.

    Time frame: 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).

    Time frame: three months

Other outcomes

  1. 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.

    Time frame: Three years

07

Study locations

5 of 5 sites recruiting
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References and documents

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 33393666 ↗
  • 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. PubMed 30253801 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05202626
Lead sponsor
Chinese Academy of Sciences
Responsible party
Di Dong (Professor, Chinese Academy of Sciences) — Principal investigator
First posted
Jan 21, 2022
Start date
Dec 1, 2021
Primary completion
Oct 30, 2023 (estimated)
Completion
Jun 28, 2025 (estimated)
Last update
Oct 17, 2023

Study contacts

Di Dong, Ph.D
Contact
di.dong@ia.ac.cn
+86 010-82618465
Yali Zang, ph.D
Contact
yali.zang@ia.ac.cn

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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