Thyroid CancerNCT07752277
Quantitative Pharmacology-Based Dose Adjustment Protocol in Postoperative Thyroid Cancer Patients
An observational study of Thyroid Cancer, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
Through pharmacometric approaches-including modeling, mathematics, and statistics-this work aims to refine the levothyroxine sodium tablet (brand name: Euthyrox) dosing strategy in post-thyroidectomy cancer patients, enabling individualized precision dosing to minimize side effects and maximize therapeutic outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2022to 23 Feb 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative Thyroid Cancer Patients
Who may be able to join
- Aged 18-65 years, inclusive, regardless of sex.
- Able to fully understand the study and voluntarily sign the informed consent form.
- Histologically or cytologically confirmed advanced or metastatic thyroid cancer, treatment-naïve, and requiring total or near-total thyroidectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- No clinically significant contraindications to surgery.
- Body weight ≥50.0 kg for males and ≥45.0 kg for females, with a body mass index (BMI) of 19.0-26.0 kg/m², inclusive.
- Able to maintain regular daily routines, communicate effectively with the investigator, comply with all study requirements, and adhere to scheduled study visits, treatment plans, and laboratory assessments.
- Adequate baseline organ function at the screening visit, as demonstrated by local laboratory values meeting the protocol-specified eligibility requirements.
Who cannot join
- Thyroid cancer patients for whom the planned or completed thyroidectomy does not meet the criteria for total or near-total thyroidectomy.
- Prior treatment for thyroid cancer, including surgery and/or pharmacological treatment.
- Major surgery, including radiosurgery, or significant traumatic injury within 2 weeks prior to randomization.
- History of another malignancy within 3 years prior to initiation of study treatment.
- Known history of a positive human immunodeficiency virus (HIV) test.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; chronic or resolved HBV or HCV infection is permitted.
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- Congenital or acquired immunodeficiency.
- History of clinically significant drug allergy or atopic allergic disease (e.g., asthma, urticaria, or eczematous dermatitis), or known hypersensitivity to Euthyrox (levothyroxine sodium) or any of its excipients.
- Pregnant or breastfeeding females.
Trial locations and contacts
1 site in 1 country.
About this study
Through pharmacometric approaches-including modeling, mathematics, and statistics-this work aims to refine the levothyroxine sodium tablet (brand name: Euthyrox) dosing strategy in post-thyroidectomy cancer patients, enabling individualized precision dosing to minimize side effects and maximize therapeutic outcomes.
- Conditions
- Thyroid Cancer
- Keywords
- Levothyroxine, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on a stable-dose regimen of Euthyrox (levothyroxine sodium tablets) following total or near | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb)
Using mathematical and statistical methods (PopPK/PD) grounded in quantitative pharmacology to quantitatively describe, explain, and predict drug effects in vivo.
Measured: Preoperatively after enrollment, 19:00 on the day of surgery, and before medication on postoperative day 1 (patients accurately recorded the administration time to the minute; the medication time was set at 7:00), 7:30, 8:00, 8:30, and 9:00 on postoperat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start6 Dec 2022
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752277
- Sponsor's protocol ID
- YJKY20220012
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 13 Aug 2026
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Pharmacology-Based Dose Adjustment Protocol in Postoperative Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT07752277
- Acronym / sponsor ID
- YJKY20220012
- Conditions
- Thyroid Cancer
- Keywords
- Levothyroxine, Pharmacokinetics, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 7 Aug 2026 (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.
Through pharmacometric approaches-including modeling, mathematics, and statistics-this work aims to refine the levothyroxine sodium tablet (brand name: Euthyrox) dosing strategy in post-thyroidectomy cancer patients, enabling individualized precision dosing to minimize side effects and maximize therapeutic outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on a stable-dose regimen of Euthyrox (levothyroxine sodium tablets) following total or near | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative Thyroid Cancer Patients
Key inclusion criteria (8 listed)
- Aged 18-65 years, inclusive, regardless of sex.
- Able to fully understand the study and voluntarily sign the informed consent form.
- Histologically or cytologically confirmed advanced or metastatic thyroid cancer, treatment-naïve, and requiring total or near-total thyroidectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- No clinically significant contraindications to surgery.
Key exclusion criteria (9 listed)
- Thyroid cancer patients for whom the planned or completed thyroidectomy does not meet the criteria for total or near-total thyroidectomy.
- Prior treatment for thyroid cancer, including surgery and/or pharmacological treatment.
- Major surgery, including radiosurgery, or significant traumatic injury within 2 weeks prior to randomization.
- History of another malignancy within 3 years prior to initiation of study treatment.
- Known history of a positive human immunodeficiency virus (HIV) test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb)
Time frame: Preoperatively after enrollment, 19:00 on the day of surgery, and before medication on postoperative day 1 (patients accurately recorded the administration time to the minute; the medication time was set at 7:00), 7:30, 8:00, 8:30, and 9:00 on postoperat
Using mathematical and statistical methods (PopPK/PD) grounded in quantitative pharmacology to quantitatively describe, explain, and predict drug effects in vivo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Zhejiang Provincial People's 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 8 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: finished, as of the sponsor's last update on 13 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb) (time frame: Preoperatively after enrollment, 19:00 on the day of surgery, and before medication on postoperative day 1 (patients accurately recorded the administration time to the minute; the medication time was set at 7:00), 7:30, 8:00, 8:30, and 9:00 on postoperat). 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 13 Aug 2026.