Thyroid CancerPhase 2NCT06087068
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
A Phase 2 study testing Thyroxine in people with Thyroid Cancer and Surgery, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and the number of pathological lymph node micrometastases (<0.2cm) ≤5 were defined as the low recurrence risk group. Read more about this study
- Who is it for?
- Ages 18 months to 70 years
- Conditions the study is for
- Thyroid Cancer, Surgery, Recurrence
- What is being tested?
- Thyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2026
- Phase
- Phase 2
- 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 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) Age 18-70 years old, ECOG score 0-2;
- (2) Patients with the maximum diameter of unilateral thyroid nodules ≤4.0cm by ultrasound, papillary thyroid carcinoma diagnosed by preoperative cytology (Bethesda grade VI) or intraoperative freezing, and planned to undergo thyroid lobectomy;
- (3) No clinical lymph node metastasis (cN0);No extrathyroidal extension, and the number of pathological lymph node micrometastasis (<0.2cm) was ≤5.
- (4) no serious medical diseases and major organ dysfunction, such as blood routine, liver, kidney, heart, lung function; No previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass excision except clinical);
- (5) Fully understand this study, have the ability to complete treatment, have follow-up conditions and voluntarily sign informed consent.
Who cannot join
- (1) History of malignancy in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
- (2) The contralateral thyroid nodules were evaluated by preoperative ultrasound, and the patients with suspicious nodules who underwent fine-needle aspiration cytology and could not confirm the benign or malignant nodules (Bethesda grade I, III-V) were excluded.
- (3) Cervical lymph node metastasis was evaluated before surgery. Cytological aspiration and Tg eluent determination were performed on suspicious lymph nodes. If cytology was negative and Tg eluent was not higher than the normal range, it was not considered as exclusion criteria. The patients who were sent for intraoperative examination and showed metastasis were excluded.
- (4) cytological aspiration or intraoperative freezing suspected non-papillary thyroid carcinoma (follicular carcinoma, medullary carcinoma, poorly differentiated or undifferentiated carcinoma) or high-risk subtypes of papillary thyroid carcinoma (high cell type);
- (5) pregnant or lactating women；
- (6) A history of drug use or drug abuse within the past 1 year;
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- (7) Participants who had participated in other clinical trials within 4 weeks before enrollment;
- (8) The patient is unable to accept the preservation of the contralateral gland or cannot cooperate with subsequent thyroid hormone replacement therapy.
- (9) The investigator assesses subjects who are unsuitable for the trial for other reasons, or who are not expected to complete the study.
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
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
jie liu, MD, 8610-87787180
About this study
Official title: A Prospective, Single-arm Phase II Study of Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and the number of pathological lymph node micrometastases (<0.2cm) ≤5 were defined as the low recurrence risk group. After total thyroidectomy and radioiodine treatment, the probability of disease-free status (irritant Tg<1ng/ml, no evidence of other disease recurrence) is about 78%-91%, and the probability of structural recurrence is about 1%-10%. In recent years, due to the further understanding of PTC, surgeons tend to become more conservative in treatment, such as active observation or reducing the extent of surgery. The indication for lobectomy has been extended to tumors <4cm without extrathyroidal extension and clinical lymph node metastasis. For patients treated with lobectomy, current guidelines recommend that Thyroid Stimulating Hormone (TSH) be controlled at 0.5-2 mU/L, but evidence on the prognostic benefits of this TSH inhibition range is lacking.In recent years, a number of studies have suggested that if postoperative TSH in low-risk patients after lobectomy is acceptable within the reference range, it means that a considerable number of patients have a high probability of not receiving thyroxine replacement therapy after surgery, which can significantly improve their quality of life.A previous retrospective study from our institute showed no significant association between TSH levels after lobectomy and prognosis.The aim of this study was to evaluate the benefits and risks of postoperative TSH levels within the reference range (0.4-5 mU/L) in patients with low-risk papillary thyroid cancer who underwent lobectomy.In order to improve the effect of longer recurrence and death time of PTC, the investigators also performed postoperative thyroglobulin and its antibody for short-term treatment response evaluation.
- Conditions
- Thyroid Cancer, Surgery, Recurrence
- Being tested
- Thyroxine
- Keywords
- thyroid cancer, lobectomy, TSH replacement, recurrence
- Medical subject headings
- Thyroid Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroxineDrug
The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L) Receives: Drug: Thyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
recurrence-free survival
Measured: 2 year
Secondary outcomes (1)
thyroid function
biochemical incomplete (rising serum Tg)
Measured: 1 year; 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liu jie, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087068
- Sponsor's protocol ID
- Cancer
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Phase II Study of Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06087068
- Acronym / sponsor ID
- Cancer
- Conditions
- Thyroid Cancer, Surgery, Recurrence
- Keywords
- thyroid cancer, lobectomy, TSH replacement, recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Oct 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.
Papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and the number of pathological lymph node micrometastases (<0.2cm) ≤5 were defined as the low recurrence risk group. After total thyroidectomy and radioiodine treatment, the probability of disease-free status (irritant Tg<1ng/ml, no evidence of other disease recurrence) is about 78%-91%, and the probability of structural recurrence is about 1%-10%. In recent years, due to the further understanding of PTC, surgeons tend to become more conservative in treatment, such as active observation or reducing the extent of surgery. The indication for lobectomy has been extended to tumors <4cm without extrathyroidal extension and clinical lymph node metastasis. For patients treated with lobectomy, current guidelines recommend that Thyroid Stimulating Hormone (TSH) be controlled at 0.5-2 mU/L, but evidence on the prognostic benefits of this TSH inhibition range is lacking.In recent years, a number of studies have suggested that if postoperative TSH in low-risk patients after lobectomy is acceptable within the reference range, it means that a considerable number of patients have a high probability of not receiving thyroxine replacement therapy after surgery, which can significantly improve their quality of life.A previous retrospective study from our institute showed no significant association between TSH levels after lobectomy and prognosis.The aim of this study was to evaluate the benefits and risks of postoperative TSH levels within the reference range (0.4-5 mU/L) in patients with low-risk papillary thyroid cancer who underwent lobectomy.In order to improve the effect of longer recurrence and death time of PTC, the investigators also performed postoperative thyroglobulin and its antibody for short-term treatment response evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: ThyroxineThe treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L) |
Who may qualify
- Ages
- 18 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- (1) Age 18-70 years old, ECOG score 0-2;
- (2) Patients with the maximum diameter of unilateral thyroid nodules ≤4.0cm by ultrasound, papillary thyroid carcinoma diagnosed by preoperative cytology (Bethesda grade VI) or intraoperative freezing, and planned to undergo thyroid lobectomy;
- (3) No clinical lymph node metastasis (cN0);No extrathyroidal extension, and the number of pathological lymph node micrometastasis (<0.2cm) was ≤5.
- (4) no serious medical diseases and major organ dysfunction, such as blood routine, liver, kidney, heart, lung function; No previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass excision except clinical);
- (5) Fully understand this study, have the ability to complete treatment, have follow-up conditions and voluntarily sign informed consent.
Key exclusion criteria (9 listed)
- (1) History of malignancy in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
- (2) The contralateral thyroid nodules were evaluated by preoperative ultrasound, and the patients with suspicious nodules who underwent fine-needle aspiration cytology and could not confirm the benign or malignant nodules (Bethesda grade I, III-V) were excluded.
- (3) Cervical lymph node metastasis was evaluated before surgery. Cytological aspiration and Tg eluent determination were performed on suspicious lymph nodes. If cytology was negative and Tg eluent was not higher than the normal range, it was not considered as exclusion criteria. The patients who were sent for intraoperative examination and showed metastasis were excluded.
- (4) cytological aspiration or intraoperative freezing suspected non-papillary thyroid carcinoma (follicular carcinoma, medullary carcinoma, poorly differentiated or undifferentiated carcinoma) or high-risk subtypes of papillary thyroid carcinoma (high cell type);
- (5) pregnant or lactating women；
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 |
|---|---|---|
| ThyroxineThe treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L) | Drug | test group |
Primary outcome
recurrence
Time frame: 2 year
recurrence-free survival
1 secondary outcome
thyroid function
Time frame: 1 year; 2 year
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 17 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thyroxine in people with Thyroid Cancer and Surgery, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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: looking for participants now, as of the sponsor's last update on 17 Oct 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 jie liu (+861087787180, liujie10-11@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 2 year). 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 17 Oct 2023.