Ultrasound-guided Thermal Ablation for Papillary Thyroid... | NCT06733740

Studies
Ultrasound-guided Thermal Ablation for Papillary Thyroid Carcinoma

NCT06733740

Sponsor

Chinese PLA General Hospital

Status

Recruiting

Last Update Posted

Feb 14, 2025Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Papillary Thyroid Cancer

Interventions

ultrasound-guided thermal ablation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2024Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Dec 6, 2024

First Submission Date that Met QC Criteria

Dec 12, 2024

First Posted Date

Dec 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2025

Last Update Posted Date

Feb 14, 2025Actual

Description Module

Brief Summary

To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma

Detailed Description

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound-guided thermal ablation	Procedure	ultrasound-guided thermal ablation to treat tumor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of disease progression	cervical lymph node metastases, recurrent tumors and persistent tumors confirmed by pathology	through study completion, an average of 6 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of complications	complications of ablation	1 week
Rate of tumor disappearance	complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients age between 18 and 80 year old, both sex
papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
the largest diameter ≤2.0 cm
no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
follow-up period ≥12 months

Exclusion Criteria:

patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
history of neck radiation
coagulation disorder, serious heart, respiratory, liver, or renal failure
dysfunction of the vocal cord on the opposite side

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with papillary thyroid carcinoma who refuse surgery or active surveillance and choose thermal ablation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Yan, MD	Contact	13811237313 ext 86		gemma-y@163.com

Overall Officials

Name	Affiliation	Role
Yukun Luo	Chinese PLA General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100853	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077273	Thyroid Cancer, Papillary

Ancestor Terms

ID	Term
D000231	Adenocarcinoma, Papillary
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020728	Transurethral Resection of Prostate

Ancestor Terms

ID	Term
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided