Safety and Quality of Life of Three Treatment Strategies for Low-Risk Papillary Thyroid Microcarcinoma
NCT ID: NCT07249125
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1630 participants
OBSERVATIONAL
2025-12-01
2039-06-01
Brief Summary
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The study aims to collect standardized, real-world clinical data from participating centers. Patients will receive one of the three treatment strategies according to clinical judgment and personal preference. The study team will prospectively follow participants to record safety events, disease progression, and patient-reported quality of life outcomes.
By comparing the outcomes among the three treatment groups, this registry seeks to provide evidence to support personalized and evidence-based decision-making for the management of low-risk PTMC.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical Resection
Participants undergo standard thyroid surgery (lobectomy or total thyroidectomy) for low-risk papillary thyroid microcarcinoma. Outcomes on safety, complications, and postoperative quality of life are collected prospectively.
No interventions assigned to this group
Thermal Ablation
Participants receive minimally invasive thermal ablation, such as radiofrequency or microwave ablation, for papillary thyroid microcarcinoma. Data include procedural safety, ablation completeness, and patient-reported quality of life.
No interventions assigned to this group
Active Surveillance
Participants choose active surveillance instead of immediate intervention. Regular follow-up with ultrasound and clinical assessment is conducted to monitor tumor progression, safety events, and quality of life over time.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* No evidence of extrathyroidal extension on imaging studies.
* No clinical or radiologic evidence of cervical lymph node metastasis.
* No evidence of distant metastasis.
* Histopathological confirmation of papillary thyroid carcinoma.
* The patient has provided written informed consent and agrees to select one of the predefined management strategies (surgical resection, thermal ablation, or active surveillance).
Exclusion Criteria
* Imaging findings (ultrasound/CT/MRI) suggestive of extrathyroidal extension.
* Tumor located adjacent to critical structures (e.g., trachea, esophagus, or recurrent laryngeal nerve) with possible invasion risk.
* History of thyroidectomy, radiofrequency/microwave/laser ablation, or radioactive iodine therapy.
* Failure to provide written informed consent.
18 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Locations
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Xijing hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20252532-C-1
Identifier Type: -
Identifier Source: org_study_id
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