A Prospective, Open-label, Multicenter, Randomized Controlled Phase III

Status Recruiting

Clinical Trial Summary

papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis. Surgery is the primary treatment for PTC, and occult lymph node metastasis is not uncommon (20%-80%).The lymph node metastasis of PTC is mostly along the lymphatic drainage path station by station, and most of the first metastasis is to the central lymph node. According to the 2015 American Thyroid Association recommendation, prophylactic central lymph node dissection is recommended for patients with primary T3-4 or cN1b without central lymph node involvement. However, PTC with primary site T1-2, no external invasion and cN0 could not be dissected by central lymph node.Previous studies have suggested that prophylactic dissection should be performed to improve disease-specific survival, reduce local recurrence, improve recurrence risk and treatment response assessment, and help RAI decision making. Although routine prophylactic central lymph node dissection may detect occult lymph node metastasis, the need for further dissection of the recurrent laryngeal nerve and the parathyroid gland may lead to an increased incidence of complications, while its effect on reducing the risk of recurrence and improving prognosis is unclear, and the impact on long-term outcomes may be small.Previous retrospective studies in our institution have shown that routine central neck dissection does not significantly reduce the risk of recurrence. This study was designed to evaluate the benefits and risks of prophylactic central lymph node dissection in cT1b-T2N0 patients with papillary thyroid carcinoma. In order to ameliorate the effects of relapse and long time of death of PTC, thyroglobulin and its antibodies were also evaluated for short-term treatment response after surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06082180
Study type	Interventional
Source	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact	jie liu
Phone	+861087787180
Email	liujie10-11@vip.163.com
Status	Recruiting
Phase	Phase 3
Start date	July 1, 2022
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05774535` - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn	`NCT04224792` - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors	N/A
Completed	`NCT01728623` - A Study of E7080 in Subjects With Advanced Thyroid Cancer	Phase 2
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT02911155` - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting	`NCT05025046` - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting	`NCT03978351` - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed	`NCT02658513` - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1
Completed	`NCT02375451` - Effect of Childhood Radioiodine Therapy on Salivary Function	N/A
Withdrawn	`NCT01994200` - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients	Phase 1/Phase 2
Terminated	`NCT01403324` - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer	N/A
Completed	`NCT00970359` - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244	N/A
Completed	`NCT00439478` - Dental Safety Profile of High-Dose Radioiodine Therapy	Phase 4
Completed	`NCT00223158` - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer	N/A
Active, not recruiting	`NCT03246958` - Nivolumab Plus Ipilimumab in Thyroid Cancer	Phase 2
Active, not recruiting	`NCT04544111` - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	Phase 2
Completed	`NCT04876287` - Salivary dysfuncTion After Radioiodine Treatment
Recruiting	`NCT06073223` - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer	N/A
Recruiting	`NCT06037174` - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms