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RecruitingNCT07488325Updated Apr 1, 2026

Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images

An observational study in Thyroid Nodule, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
396
Ages
18 Years to 80 Years
Sex
All
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Study summary

The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.

Read the detailed description

Objectives: To develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.

Materials and Methods: A ultrasound model, a cytology model, and a fusion model were constructed in this single-center retrospective diagnostic accuracy test. Consecutive patients with Bethesda III thyroid nodules who underwent conventional US examination and fine-needle aspirations were included between January 2016 and December 2024 in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The reference standard was postoperative histopathology or BRAFV600E mutation. Receiver operating characteristic curve analysis was used to evaluate the diagnostic performance, and decision curve analysis was used to assess the clinical utility.

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Conditions studied

  • Thyroid Nodule

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Keywords

  • Thyroid Nodule
  • Atypia of Undetermined Significance
  • Multimodal Deep Learning
  • Ultrasound
  • Cytology Whole-Slide Image
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In context

Thyroid Nodule

207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.

This study's planned enrollment of 396 is above the median of 161 across 82 observational studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a Bethesda Ⅲ thyroid nodule

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

  • (a) Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda Ⅲ.
  • (b) Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions,.
  • (c) Availability of at least one ultrasound image acquired prior to surgery.

Exclusion criteria

Exclusion Criteria:

  • (a) Patients without confirmation by surgical pathology,.
  • (b) Patients without any available or usable ultrasound images.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
396 participants (estimated)
Patient registry
No

Groups and cohorts

  • Benign thyroid nodule

    Confirmed by histopathology.

    Other: Histopathology or cytopathology.

  • Malignant thyroid nodule

    Confirmed by histopathology.

    Other: Histopathology or cytopathology.

Interventions

  • OtherHistopathology or cytopathology.

    This is a observation stufy.

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What researchers measure

Primary outcomes

  1. Pathological diagnosis.

    WHO guidelines.

    Time frame: One month after the surgery.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07488325
Responsible party
Sponsor
First posted
Mar 23, 2026
Start date
Mar 1, 2026
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 15, 2026 (estimated)
Last update
Apr 1, 2026

Study contacts

Jingliang Ruan, Ph.D.
Contact
ruanjl3@mail.sysu.edu.cn
+8613694202230
Xinmin Xiao, B.S.
Contact
+8618420058253
Jingliang Ruan, Ph.D.
principal investigator · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Oversight

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

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