NCT06463392

Brief Summary

Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Novel diagnostic tools are therefore clinically significant. In this study, the investigators seek to ask if a deep-learning-based model shows a significantly higher sensitivity than radiologists. With a cross-sectional design, the investigators aim to recruit 312 participants in Sun Yat-sen Memorial Hospital, Guangzhou, China that meet the eligibility criteria.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress28%
Jul 2024Dec 2030

First Submitted

Initial submission to the registry

May 22, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

5.5 years

First QC Date

May 22, 2024

Last Update Submit

September 27, 2024

Conditions

Nasopharyngeal CarcinomaHerpesvirus 4, Human

Keywords

Nasopharyngeal CarcinomaSkull-base OsteonecrosisRadiotherapyEpstein-Barr Virus

Outcome Measures

Primary Outcomes (2)

  • Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.

    Baseline

  • Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.

    Baseline

Secondary Outcomes (12)

  • Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.

    Baseline

  • Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.

    Baseline

  • F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.

    Baseline

  • Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.

    Baseline

  • Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.

    Baseline

  • +7 more secondary outcomes

Other Outcomes (13)

  • The number of white blood cells in the peripheral blood.

    Baseline

  • The number of neutrophils in the peripheral blood.

    Baseline

  • The number of basophils in the peripheral blood.

    Baseline

  • +10 more other outcomes

Study Arms (2)

Case

Histologically confirmed sbORN that meets the eligibility criteria.

Other: No Intervention: Observational Cohort

Control

Histologically confirmed NPC recurrence that meets the eligibility criteria.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortOTHER

No intervention is scheduled for this observational study.

CaseControl

Eligibility Criteria

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

All populations that meet the eligibility criteria.

You may qualify if:

  • Equal to or older than 18 years old.
  • A history of histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma.
  • A history of radical radiotherapy at nasopharynx.
  • Complete remission six months post radical radiotherapy according to RECIST 1.1.
  • No evidence of distant metastasis upon recruitment.
  • Diagnosis of sbORN given by senior radiologist with 2-4 Likert scores.
  • Consent to biopsy awake or under general anesthesia.
  • Consent to perform blood tests, EBV DNA, EBV IgAs, and MRI inspection of nasopharynx and neck.
  • With a written consent.

You may not qualify if:

  • MRI artifacts or other factors that interfere radiological diagnosis and region of interest contouring.
  • Suspected lesion is not confined to nasopharynx and skull-base.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal CarcinomaEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Central Study Contacts

Xiang-Wei Kong, Ph.D.

CONTACT

0086-020-34071439kongxw8@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 17, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

October 1, 2024

Record last verified: 2024-09

Locations

CN(1)