Thyroid CancerNCT06851260
The Importance of Thymus Anatomy to the Radical Resection of Thyroid Cancer Surgery and the Protection of Parathyroid Function
A study testing Fine-dissection of the thymus in people with Thyroid Cancer and Surgery, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Thyroid cancer is one of the most common endocrine malignancies. In the past three decades, the incidence rate of thyroid cancer has continued to rise rapidly in many countries and regions around the world. The incidence rate of thyroid cancer in China is increasing year by year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Surgery
- What is being tested?
- Fine-dissection of the thymus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2025to 30 Mar 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with thyroid cancer who require total thyroidectomy and bilateral central lymph node dissection.
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
- Age at the time of signing the informed consent form is between 18 and 80 years old, regardless of gender.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1.
- Expected survival period is not less than 1 year.
- Male and female patients of childbearing age agreed to use reliable methods of contraception before entering the trial, during the research process, and up to 8 weeks after discontinuation of medication.
- Good organ function:
- Hematology: Absolute neutrophil count (ANC) ≥ 1500/μ L; Platelets ≥ 100000/μ L; Hemoglobin ≥ 9.0g/dL or ≥ 5.6 mmol/L; Kidney: Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance rate (CrCl) ≥ 60 mL/min (using the Cock Gault formula); Liver: For subjects with total bilirubin levels ≤ 1.5 × ULN or for subjects with total bilirubin levels>1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; Endocrine system: Thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, the subject still meets the inclusion criteria; Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for subjects undergoing anticoagulant therapy as long as PT or aPTT is within the prescribed range of use of the anticoagulant drug; Willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the research plan.
Who cannot join
- There are locally advanced unresectable or metastatic diseases.
- History of non infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease requiring steroid treatment.
- Known history of active tuberculosis.
- Known to have active infections that require systematic treatment.
- Any subjects with known or suspected autoimmune diseases or immune deficiencies.
- Uncontrolled active hepatitis B (defined as hepatitis B B virus surface antigen [HBsAg] test result in screening period is positive and HBV-DNA test value is higher than the upper limit of normal value in the laboratory department of the research center.
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- Subjects with HBV-DNA levels<500 IU/mL within 28 days prior to randomization, who have received local standard antiviral treatment for at least 14 days and are willing to continue receiving antiviral treatment during the study period, are eligible for enrollment; Subjects with active hepatitis C (defined as those who test positive for hepatitis C virus surface antibody [HCsAb] and HCV-RNA during the screening period).
- Known human immunodeficiency virus (HIV) infection (known to be HIV antibody positive).
- Administer a live vaccine within 30 days prior to the first dose.
- Have ≥ grade 2 peripheral neuropathy.
- Has experienced severe allergic reactions to other monoclonal antibodies.
- Known to have serious or uncontrolled underlying diseases; Including but not limited to hemodynamic instability cardiovascular events, symptomatic cerebrovascular events, and Child Pugh A or higher liver cirrhosis that occur within 6 months.
About this study
Official title: A Multi-center Prospective Randomized Controlled Study on the Anatomical Relationship of the Thymus to the Radical Resection of Thyroid Cancer and the Protection of Parroid Function
Thyroid cancer is one of the most common endocrine malignancies. In the past three decades, the incidence rate of thyroid cancer has continued to rise rapidly in many countries and regions around the world. The incidence rate of thyroid cancer in China is increasing year by year. The standardized incidence rate increased from 1.4/100000 person years in 1990 to 14.65/100000 person years in 2016. It has become the seventh malignant tumor in China with incidence rate, especially the incidence rate of women. Although differentiated thyroid cancer (DTC) has a low degree of malignancy, it still poses a threat to the life, health, and quality of life of patients. Due to its low mortality rate and long survival period, standardized diagnosis, treatment, and follow-up are even more necessary. The 5-year survival rate of thyroid cancer in China has increased significantly from 67.5% in 2003-2005 to 84.3% in 2012-2015, but still lags far behind the 98.3% in the United States.
The current treatment for thyroid cancer is mainly surgical treatment. The development concept of tumor surgery is first radical, followed by functional preservation, and finally aesthetic incision. Standardized and thorough radical surgery is the most critical link to improve patient prognosis and reduce the occurrence of complications. Lymph node metastasis is a common cause of patient recurrence. According to literature reports, the central lymph node metastasis rate after DTC surgery is 24% -64%, which affects the prognosis and quality of life of patients, often requiring secondary surgery, increasing the incidence of postoperative complications and patient burden. Therefore, thyroid cancer surgery requires standardized and thorough neck lymph node dissection. Based on surgical experience and autopsy research, several pre tracheal lymph nodes are often hidden in the deep surface of the thymus from the inferior pole of the thyroid to the upper edge of the unnamed artery. Postoperative recurrence of central lymph nodes often occurs in this area. Therefore, during the initial surgery, the neck segment of the thymus must be freed and pulled away to the shallow layer to thoroughly clean the pre tracheal lymph nodes hidden in the deep surface of the thymus. A considerable number of zone VII lymph nodes can also be pulled out to make the central lymph node cleaning more thorough. However, current surgical standards and guidelines do not emphasize the importance of thymus anatomy.
- Conditions
- Thyroid Cancer, Surgery
- Being tested
- Fine-dissection of the thymus
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine-dissection of the thymusProcedure or surgery
In thyroid surgery, precise dissection and preservation of thymus tissue are used to improve the protection of the lower parathyroid gland function and increase the curative effect of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| thymus anatomy | Experimental | Fine dissection and preservation of thymus tissue are required during surgery. Receives: Procedure: Fine-dissection of the thymus |
| non-thymus anatomy | No intervention | Conventional surgical method for central lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of surgery
Count the number of central lymph node dissection and positive lymph nodes in routine pathological examination after surgery. Follow up neck ultrasound will be conducted at 3 months, 6 months, and 1 year after surgery, and then every 6 months.
Measured: 13 months
Secondary outcomes (1)
the PTH level after surgery
Dynamic monitoring of PTH changes will be conducted at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year after surgery until disease progression or recurrence or initiation of new anti-tumor treatment, whichever occurs first.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion30 Mar 2026 (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 Tianjin Medical University Cancer Institute and 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851260
- Sponsor's protocol ID
- E20241348
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Randomized Controlled Study on the Anatomical Relationship of the Thymus to the Radical Resection of Thyroid Cancer and the Protection of Parroid Function
- ClinicalTrials.gov ID
- NCT06851260
- Acronym / sponsor ID
- E20241348
- Conditions
- Thyroid Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
Thyroid cancer is one of the most common endocrine malignancies. In the past three decades, the incidence rate of thyroid cancer has continued to rise rapidly in many countries and regions around the world. The incidence rate of thyroid cancer in China is increasing year by year. The standardized incidence rate increased from 1.4/100000 person years in 1990 to 14.65/100000 person years in 2016. It has become the seventh malignant tumor in China with incidence rate, especially the incidence rate of women. Although differentiated thyroid cancer (DTC) has a low degree of malignancy, it still poses a threat to the life, health, and quality of life of patients. Due to its low mortality rate and long survival period, standardized diagnosis, treatment, and follow-up are even more necessary. The 5-year survival rate of thyroid cancer in China has increased significantly from 67.5% in 2003-2005 to 84.3% in 2012-2015, but still lags far behind the 98.3% in the United States.
The current treatment for thyroid cancer is mainly surgical treatment. The development concept of tumor surgery is first radical, followed by functional preservation, and finally aesthetic incision. Standardized and thorough radical surgery is the most critical link to improve patient prognosis and reduce the occurrence of complications. Lymph node metastasis is a common cause of patient recurrence. According to literature reports, the central lymph node metastasis rate after DTC surgery is 24% -64%, which affects the prognosis and quality of life of patients, often requiring secondary surgery, increasing the incidence of postoperative complications and patient burden. Therefore, thyroid cancer surgery requires standardized and thorough neck lymph node dissection. Based on surgical experience and autopsy research, several pre tracheal lymph nodes are often hidden in the deep surface of the thymus from the inferior pole of the thyroid to the upper edge of the unnamed artery. Postoperative recurrence of central lymph nodes often occurs in this area. Therefore, during the initial surgery, the neck segment of the thymus must be freed and pulled away to the shallow layer to thoroughly clean the pre tracheal lymph nodes hidden in the deep surface of the thymus. A considerable number of zone VII lymph nodes can also be pulled out to make the central lymph node cleaning more thorough. However, current surgical standards and guidelines do not emphasize the importance of thymus anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thymus anatomy | Experimental | Procedure: Fine-dissection of the thymusFine dissection and preservation of thymus tissue are required during surgery. |
| non-thymus anatomy | No intervention | –Conventional surgical method for central lymph node dissection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with thyroid cancer who require total thyroidectomy and bilateral central lymph node dissection.
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
- Age at the time of signing the informed consent form is between 18 and 80 years old, regardless of gender.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1.
- Expected survival period is not less than 1 year.
Key exclusion criteria (12 listed)
- There are locally advanced unresectable or metastatic diseases.
- History of non infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease requiring steroid treatment.
- Known history of active tuberculosis.
- Known to have active infections that require systematic treatment.
- Any subjects with known or suspected autoimmune diseases or immune deficiencies.
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 |
|---|---|---|
| Fine-dissection of the thymusIn thyroid surgery, precise dissection and preservation of thymus tissue are used to improve the protection of the lower parathyroid gland function and increase the curative effect of the surgery. | Procedure or surgery | thymus anatomy |
Primary outcome
The effectiveness of surgery
Time frame: 13 months
Count the number of central lymph node dissection and positive lymph nodes in routine pathological examination after surgery. Follow up neck ultrasound will be conducted at 3 months, 6 months, and 1 year after surgery, and then every 6 months.
1 secondary outcome
the PTH level after surgery
Time frame: 13 months
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 28 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fine-dissection of the thymus in people with Thyroid Cancer and Surgery, run by Tianjin Medical University Cancer Institute and Hospital.
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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of surgery (time frame: 13 months). 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 28 Feb 2025.