NCT06554652 Selective Neck Dissection Versus Modified Neck Dissection in PTC
| NCT ID | NCT06554652 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2024-11-19 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed PTC; * Age range: 14-80 years old; * Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck * Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and \<1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels); * Thyroid tumors without extra thyroidal extension; * Enough thyroid volume to inject tracer. Exclusion Criteria: * Previous neck surgery; * Bilateral neck lymph node dissection; * Distant metastases; * High risk pathological subtypes or the presence of other high-risk factors for recurrence; * Previous treatment for thyroid cancer other than endocrine therapy; * The patient is unable to cooperate with follow-up.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06554652 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06554652 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT06554652 currently recruiting?
Yes, NCT06554652 is actively recruiting participants. Contact the research team at neck130@sina.com for enrollment information.
Where is the NCT06554652 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06554652 clinical trial?
NCT06554652 is sponsored by Fudan University. The trial plans to enroll 250 participants.
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