Thyroid CancerNCT06037174
Comparison of Quality of Life in Patients with Differentiated Thyroid Carcinoma Undergoing Different Surgery
An observational study of Thyroid Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment. Traditional open surgery would leave a scar on the neck. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- minimally invasive procedure and Conventional Open Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Age ≥18 years and < 70 years;
- Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary thyroid carcinoma, follicular carcinoma);
- stage T1~T3a, N0~N1a, M0;
- Ability to read and write Chinese;
- Willingness to follow up.
Who cannot join
- Age < 18 years old or ≥70 years old;
- Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid carcinoma;
- Aggressive histology: tall cell, columnar cell, hobnail variant, etc.
- Mixed with medullary carcinoma or anaplastic thyroid carcinoma;
- High risk of recurrence (according to ATA guideline);
- Lateral cervical lymph node metastasis or distant metastasis;
Show all 9Show fewer
- Suffer from other malignant tumors;
- History of thyroid surgery or cervical lymph node dissection;
- Cognition or behavior impairment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hopsital
Guangzhou, Guangdong, 510289
Xiaoming Huang, Professor, 13602808820, hxming@mail.sysu.edu.cn
Peiliang Lin, Doctor, 18520393810, linpliang3@mail.sysu.edu.cn
About this study
Official title: Comparison of Quality of Life Between Patients with Early Differentiated Thyroid Cancer Undergoing Minimally Invasive and Open Surgery: a Prospective Cohort Study
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment. Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing different surgery. The quality of life, voice, scar would be assessed by authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery is better than traditional open surgery in order to provide reliable evidence for clinical practice.
Read the detailed description
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a good prognosis. For early differentiated thyroid cancer, surgery is the main treatment. Traditional open surgery would leave a scar on the neck, which is especially troublesome for female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing surgery according to a prospective cohort design. The evaluation questionnaires including quality of life, voice and scar would be completed to demonstrate that minimally invasive surgery is better than traditional open surgery not only in the way of effectiveness, but also in the quality of life. We hope to provide reliable evidence for clinical practice by this study.
- Conditions
- Thyroid Cancer
- Being tested
- minimally invasive procedure, Conventional Open Surgery
- Keywords
- thyroid cancer, quality of life, minimally invasive, surgery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive procedureProcedure or surgery
different minimally invasive approach to complete thyroidectomy, including endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach (not leaving scar on the neck)
Conventional Open SurgeryProcedure or surgery
Conventional Open Surgery
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive surgery | undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc. Receives: Procedure: minimally invasive procedure | |
| traditional open surgery | undergoing thyroidectomy with tradition open surgery Receives: Procedure: Conventional Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of quality of life (SF-36)
change of the scores of the SF-36（36-item Short-Form）questionaire
Measured: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
change of quality of life (Thyca-Qol)
change of the scores of the Thyca-Qol（Thyroid Cancer-specific Quality of Life） questionaire
Measured: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes (9)
voice handicap index
assessment of quality of voice
Measured: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
scores of the surgical scar
scores of the questionaires (POSAS) about scar
Measured: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
level of thyroglobulin
an indicator to monitor tumor residual or recurrence
Measured: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
level of calcium
to indicate whether the patient have hypocalcemia
Measured: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
operation duration
time for operation
Measured: Intraoperative
blood loss
blood loss during operation
Measured: up to 1 week after surgery
postoperative drainage
drainage volume after surgery
Measured: up to 1 week after surgery
complications
complication events after surgery, e.g. hoarseness, hypocalcemia, hemorrhage, seroma
Measured: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
satisfaction of the surgery
Visual Analog Score for satisfaction
Measured: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start15 Sep 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Huang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Xiaoming Huang, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037174
- Sponsor's protocol ID
- SYSKY-2023-472-01
- Status last verified
- Dec 2023
- First submitted
- 16 Jun 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Life Between Patients with Early Differentiated Thyroid Cancer Undergoing Minimally Invasive and Open Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06037174
- Acronym / sponsor ID
- SYSKY-2023-472-01
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, quality of life, minimally invasive, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 14 Sep 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.
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment. Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing different surgery. The quality of life, voice, scar would be assessed by authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery is better than traditional open surgery in order to provide reliable evidence for clinical practice.
Detailed description
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a good prognosis. For early differentiated thyroid cancer, surgery is the main treatment. Traditional open surgery would leave a scar on the neck, which is especially troublesome for female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing surgery according to a prospective cohort design. The evaluation questionnaires including quality of life, voice and scar would be completed to demonstrate that minimally invasive surgery is better than traditional open surgery not only in the way of effectiveness, but also in the quality of life. We hope to provide reliable evidence for clinical practice by this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive surgery | – | Procedure: minimally invasive procedureundergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc. |
| traditional open surgery | – | Procedure: Conventional Open Surgeryundergoing thyroidectomy with tradition open surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (5 listed)
- Age ≥18 years and < 70 years;
- Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary thyroid carcinoma, follicular carcinoma);
- stage T1~T3a, N0~N1a, M0;
- Ability to read and write Chinese;
- Willingness to follow up.
Key exclusion criteria (9 listed)
- Age < 18 years old or ≥70 years old;
- Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid carcinoma;
- Aggressive histology: tall cell, columnar cell, hobnail variant, etc.
- Mixed with medullary carcinoma or anaplastic thyroid carcinoma;
- High risk of recurrence (according to ATA guideline);
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 |
|---|---|---|
| minimally invasive proceduredifferent minimally invasive approach to complete thyroidectomy, including endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach (not leaving scar on the neck) | Procedure or surgery | minimally invasive surgery |
| Conventional Open SurgeryConventional Open Surgery | Procedure or surgery | traditional open surgery |
Primary outcome
change of quality of life (SF-36)
Time frame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
change of the scores of the SF-36（36-item Short-Form）questionaire
change of quality of life (Thyca-Qol)
Time frame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
change of the scores of the Thyca-Qol（Thyroid Cancer-specific Quality of Life） questionaire
9 secondary outcomes
voice handicap index
Time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
scores of the surgical scar
Time frame: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
level of thyroglobulin
Time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
level of calcium
Time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
operation duration
Time frame: Intraoperative
blood loss
Time frame: up to 1 week after surgery
postoperative drainage
Time frame: up to 1 week after surgery
complications
Time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
satisfaction of the surgery
Time frame: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiaoming Huang study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Thyroid Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Huang, Professor (13602808820, hxming@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of quality of life (SF-36) (time frame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery). The study lists 2 primary outcomes in all. 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 3 Oct 2024.