Papillary Thyroid CarcinomaNCT05962892
A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Carcinoma and Thermal Ablation, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal ablation in our hospital since February 2023 was established as the study object. Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory tests, and thyroid disease-related scales such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Carcinoma, Thermal Ablation
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 28 Feb 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically proven PTC underwent ultrasound-guided percutaneous thermal ablation.
Who may be able to join
- ①≥18 years old; ② Obtain informed consent; ③ Ultrasonography showed that malignant nodules were single, the maximum diameter of nodules was ≤1cm and the distance from the capsule was ≥2mm. ④ no lymph node metastasis or other extra-glandular metastasis in the neck; ⑤ PTC was confirmed by fine needle puncture pathology; ⑥ Patients who do not meet Article 3, who still strongly request thermal ablation while fully informing the patient of the risk of recurrence, and who have been clinically assessed to be technically capable of thermal ablation Exclusion Criteria:① Pregnant or lactating patients; ② Patients with other malignant tumors and not suitable for ablation by clinical evaluation; ③ Patients who cannot tolerate surgery; ④ Patients with cognitive impairment and other conditions who cannot accurately fill in thyroid-related questionnaires.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing
Xianquan Shi, 18510085125, sonoshixq@ccmu.edu.cn
About this study
A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal ablation in our hospital since February 2023 was established as the study object. Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory tests, and thyroid disease-related scales such as fatigue, depression, and stress were collected. The influencing factors of PTC recurrence were analyzed.
- Conditions
- Papillary Thyroid Carcinoma, Thermal Ablation
- Being tested
- No Intervention
- Keywords
- Papillary Thyroid Carcinoma, cohort, Thermal Ablation, Recurrence
- Medical subject headings
- Thyroid Cancer, Papillary, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recurrence of PTC
the recurrence of PTC during follow-up
Measured: 1 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Feb 2024 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962892
- Sponsor's protocol ID
- MR-11-23-009728
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05962892
- Acronym / sponsor ID
- MR-11-23-009728
- Conditions
- Papillary Thyroid Carcinoma, Thermal Ablation
- Keywords
- Papillary Thyroid Carcinoma, cohort, Thermal Ablation, Recurrence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal ablation in our hospital since February 2023 was established as the study object. Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory tests, and thyroid disease-related scales such as fatigue, depression, and stress were collected. The influencing factors of PTC recurrence were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | – | Other: No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically proven PTC underwent ultrasound-guided percutaneous thermal ablation.
Key inclusion criteria (1 listed)
- ①≥18 years old; ② Obtain informed consent; ③ Ultrasonography showed that malignant nodules were single, the maximum diameter of nodules was ≤1cm and the distance from the capsule was ≥2mm. ④ no lymph node metastasis or other extra-glandular metastasis in the neck; ⑤ PTC was confirmed by fine needle puncture pathology; ⑥ Patients who do not meet Article 3, who still strongly request thermal ablation while fully informing the patient of the risk of recurrence, and who have been clinically assessed to be technically capable of thermal ablation Exclusion Criteria:① Pregnant or lactating patients; ② Patients with other malignant tumors and not suitable for ablation by clinical evaluation; ③ Patients who cannot tolerate surgery; ④ Patients with cognitive impairment and other conditions who cannot accurately fill in thyroid-related questionnaires.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | No Intervention |
Primary outcome
the recurrence of PTC
Time frame: 1 to 5 years
the recurrence of PTC during follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Carcinoma
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Carcinoma and Thermal Ablation, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianquan Shi, PhD (18510085125, sonoshixq@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recurrence of PTC (time frame: 1 to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.