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NCT03813173Not yet recruiting

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study

Source: ClinicalTrials.gov · Last updated 5 Jul 2019 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study is divided into three stages. In the first stage, the investigators try to explore the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate the "clinical imaging standard of cN0PTC", and randomly enroll 2000 patients under the premise of meeting the standard to establish the "predictive model of cN0-pN+PTC". In the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of "cN0-pN+PTC prediction model". In the third stage, 2 000 patients without lymph node metastasis assessed by "cNo-pN+ PTC prediction model" will be randomly divided into experimental group and control group. The experimental group will be treated with pCND, while the experimental group will be treated without pCND. The central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. The two groups will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further evaluate the "cN0-pN+PTC prediction model" scientifically.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
6000 (estimated)
First submitted
16 Jan 2019
Start date
Jan 2020
Primary completion date
Dec 2040
Lead sponsor
Zhejiang University
NCT number
NCT03813173

What you commit to

  • Study type: Interventional
  • Planned participants: 6000
  • From Jan 2020 to the primary completion date, Dec 2040
  • 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.

Other illness

  • (1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma.

Who the study is looking for

  • Phase I and II:
    • aged 18 to 80 years old;
    • the primary treatment of patients with unilateral or bilateral PTC;
    • ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
    • ultrasonography of cervical VI lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no local or global echo enhancement;
    • CT scan of cervical VI lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution;
    • patients will voluntarily enter the study after informed consent;
    • Phase III:
  • aged from 18 to 80 years old;
  • ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
  • Unilateral or bilateral PTC without lymph node metastasis assessed by "cNo-pN+ PTC prediction model";
  • patients will voluntarily enter the study after informed consent.

Age in the registry: 18 years to 80 years · 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.