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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2039-06-01

Brief Summary

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This is a prospective observational patient registry study designed to evaluate the safety and quality of life associated with three treatment strategies for patients diagnosed with low-risk papillary thyroid microcarcinoma (PTMC): surgical resection, thermal ablation, and active surveillance.

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.

Detailed Description

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Conditions

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Papillary Thyroid Microcarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* A single papillary thyroid carcinoma (PTC) lesion with a maximum diameter ≤ 1 cm confirmed by imaging.
* 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

* Ultrasound-confirmed tumor with a maximum diameter \> 1 cm.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Zhe Wang, Dr

Role: CONTACT

029-84775271

Facility Contacts

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Zhe Wang, Dr

Role: primary

029-84775271

Other Identifiers

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KY20252532-C-1

Identifier Type: -

Identifier Source: org_study_id

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