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NCT06423105Completed

Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients

Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients: a Cohort Study

Source: ClinicalTrials.gov · Last updated 23 May 2024

Brief summary (registry, in English)

The problem of false-negative lymph nodes in the central region (CLN) refers to the inability to detect lymph nodes (LN) metastasis during preoperative ultrasound examination but is confirmed by surgical and postoperative pathological examination. According to this study, the false-negative rate of CLN of patients with TC was relatively high at approximately 71.7%. The high proportion of false-negatives indicates limitations in the sensitivity of ultrasound examination, especially for detecting small LN or small metastases. The presence of false-negative CLN directly affects clinical practice. First, it may lead to insufficient selection of treatment strategies for patients with TC, thereby affecting their prognosis. Second, such false-negative results may lead surgeons to overly trust ultrasound examination during preoperative evaluation, neglecting the importance of comprehensive clinical information, and thus affecting the formulation of treatment plans. This study aimed to explore the factors influencing false-negative CLN through a cohort study and to establish a predictive model.

Status (registry)
Completed
Study type
Observational
Enrollment
6369 (actual)
First submitted
15 May 2024
Start date
1 Jan 2013
Primary completion date
31 Dec 2023
Lead sponsor
Ningning Ren
NCT number
NCT06423105

What you commit to

  • Study type: Observational
  • Participants enrolled: 6369
  • From 1 Jan 2013 to the primary completion date, 31 Dec 2023
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Cases that have not undergone thyroid and neck lymph node examination by the ultrasound department of Shandong Provincial Hospital before surgery are excluded.
  • Excluding cases of secondary surgery.

Other

  • Except for cases of recurrence.
  • Cases with incomplete clinical data and research materials are excluded.
  • Cases with enlarged lymph nodes in the central thyroid region indicated by preoperative ultrasound are excluded.
  • Cases with postoperative pathological diagnosis of benign thyroid tumors are excluded.

Who the study is looking for

  • All cases are new cases of thyroid cancer.
  • All clinical data and research materials of the cases are complete.
  • All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital.
  • All cases showed no swelling in the central lymph node status on preoperative ultrasound.
  • All cases underwent initial surgical treatment.
  • All cases were diagnosed with thyroid cancer through postoperative pathological examination.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.