Differentiated Thyroid CancerNCT06154863
Recurrence in Patients With Differentiated Thyroid Cancer
An observational study of Differentiated Thyroid Cancer, run by Assiut University.
Trial summary
The aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- RAI
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with differentiated thyroid cancer underwent total thyroidectomy.
Who may be able to join
- Patients with DTC (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors.
- Followed by ablation with RAI and underwent post RAI whole body scan.
- Having baseline TG (thyroglobulin), Anti-TG antibodies (anti thyroglobulin) and neck US.
- Patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained.
Who cannot join
- Patients who received RAI and missed follow-up.
- Patients with no surgical or pathological data.
About this study
Official title: Evaluation of Recurrence in Patients With Differentiated Thyroid Cancer
The aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy.
Read the detailed description
Thyroid cancer is the most frequent cancer of the endocrine system, and its incidence is constantly rising worldwide. This is mainly because of advances in examination modalities that have made it possible to detect smaller cancers at an early stage.
Owing to advancements in screening techniques and treatment methods, the number of patients who die from thyroid cancer is small compared to the incidence.[1]
The most common type of thyroid cancer is differentiated thyroid cancer (DTC), which includes papillary and follicular carcinomas. Women are three times more likely to develop thyroid cancer than men. [2] Adjuvant RAI131 (AT) is recommended post thyroidectomy, because of its therapeutic impact on micro-invasions or micro-metastases, to reduce the likelihood of recurrence in patients who do not have metastases but have risk of recurrence according to the Japanese guidelines and American Thyroid Association guidelines [3],[4].
AT could prolong the survival of patients with intermediate-risk DTC [5]. Additionally, a meta-analysis has shown that AT is effective in reducing recurrence in some studies but not in others, and the effect of AT on recurrence prevention, especially in high-risk DTC, remains unclear.[6].
Although there are reliable reports discussing the relationship between the success or failure of remnant ablation [7],[8], recurrence after AT is rarely reported and the number of cases is small. In addition, no study has so far discussed the relationship between the success or failure of AT or remnant ablation and recurrence or death [9],[10].
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- RAI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAIDrug
Radioactive iodine
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.
Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.
Measured: 2 years
Secondary outcomes (1)
Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant.
Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant in patients with low-intermediate-risk differentiated thyroid cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Salah Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154863
- Sponsor's protocol ID
- recurrence in thyroid cancer
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vigneri R, Malandrino P, Vigneri P. The changing epidemiology of thyroid cancer: why is incidence increasing? Curr Opin Oncol. 2015 Jan;27(1):1-7. doi: 10.1097/CCO.0000000000000148.
PubMed 25310641Sawka AM, Carty SE, Haugen BR, Hennessey JV, Kopp PA, Pearce EN, Sosa JA, Tufano RP, Jonklaas J. American Thyroid Association Guidelines and Statements: Past, Present, and Future. Thyroid. 2018 Jun;28(6):692-706. doi: 10.1089/thy.2018.0070. Epub 2018 Apr 26.
PubMed 29698130Ruel E, Thomas S, Dinan M, Perkins JM, Roman SA, Sosa JA. Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer. J Clin Endocrinol Metab. 2015 Apr;100(4):1529-36. doi: 10.1210/jc.2014-4332. Epub 2015 Feb 2.
PubMed 25642591Jeong SY, Lee SW, Kim WW, Jung JH, Lee WK, Ahn BC, Lee J. Clinical outcomes of patients with T4 or N1b well-differentiated thyroid cancer after different strategies of adjuvant radioiodine therapy. Sci Rep. 2019 Apr 3;9(1):5570. doi: 10.1038/s41598-019-42083-3.
PubMed 30944403Lee SH, Roh JL, Gong G, Cho KJ, Choi SH, Nam SY, Kim SY. Risk Factors for Recurrence After Treatment of N1b Papillary Thyroid Carcinoma. Ann Surg. 2019 May;269(5):966-971. doi: 10.1097/SLA.0000000000002710.
PubMed 29462007
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Recurrence in Patients With Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06154863
- Acronym / sponsor ID
- recurrence in thyroid cancer
- Conditions
- Differentiated Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 4 Dec 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 aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy.
Detailed description
Thyroid cancer is the most frequent cancer of the endocrine system, and its incidence is constantly rising worldwide. This is mainly because of advances in examination modalities that have made it possible to detect smaller cancers at an early stage.
Owing to advancements in screening techniques and treatment methods, the number of patients who die from thyroid cancer is small compared to the incidence.[1]
The most common type of thyroid cancer is differentiated thyroid cancer (DTC), which includes papillary and follicular carcinomas. Women are three times more likely to develop thyroid cancer than men. [2] Adjuvant RAI131 (AT) is recommended post thyroidectomy, because of its therapeutic impact on micro-invasions or micro-metastases, to reduce the likelihood of recurrence in patients who do not have metastases but have risk of recurrence according to the Japanese guidelines and American Thyroid Association guidelines [3],[4].
AT could prolong the survival of patients with intermediate-risk DTC [5]. Additionally, a meta-analysis has shown that AT is effective in reducing recurrence in some studies but not in others, and the effect of AT on recurrence prevention, especially in high-risk DTC, remains unclear.[6].
Although there are reliable reports discussing the relationship between the success or failure of remnant ablation [7],[8], recurrence after AT is rarely reported and the number of cases is small. In addition, no study has so far discussed the relationship between the success or failure of AT or remnant ablation and recurrence or death [9],[10].
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with differentiated thyroid cancer underwent total thyroidectomy.
Key inclusion criteria (4 listed)
- Patients with DTC (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors.
- Followed by ablation with RAI and underwent post RAI whole body scan.
- Having baseline TG (thyroglobulin), Anti-TG antibodies (anti thyroglobulin) and neck US.
- Patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained.
Key exclusion criteria (2 listed)
- Patients who received RAI and missed follow-up.
- Patients with no surgical or pathological data.
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 |
|---|---|---|
| RAIRadioactive iodine | Drug | – |
Primary outcome
Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.
Time frame: 2 years
Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.
1 secondary outcome
Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 25310641Vigneri R, Malandrino P, Vigneri P. The changing epidemiology of thyroid cancer: why is incidence increasing? Curr Opin Oncol. 2015 Jan;27(1):1-7. doi: 10.1097/CCO.0000000000000148.
- Background: PubMed 29698130Sawka AM, Carty SE, Haugen BR, Hennessey JV, Kopp PA, Pearce EN, Sosa JA, Tufano RP, Jonklaas J. American Thyroid Association Guidelines and Statements: Past, Present, and Future. Thyroid. 2018 Jun;28(6):692-706. doi: 10.1089/thy.2018.0070. Epub 2018 Apr 26.
- Background: PubMed 25642591Ruel E, Thomas S, Dinan M, Perkins JM, Roman SA, Sosa JA. Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer. J Clin Endocrinol Metab. 2015 Apr;100(4):1529-36. doi: 10.1210/jc.2014-4332. Epub 2015 Feb 2.
- Background: PubMed 30944403Jeong SY, Lee SW, Kim WW, Jung JH, Lee WK, Ahn BC, Lee J. Clinical outcomes of patients with T4 or N1b well-differentiated thyroid cancer after different strategies of adjuvant radioiodine therapy. Sci Rep. 2019 Apr 3;9(1):5570. doi: 10.1038/s41598-019-42083-3.
- Background: PubMed 29462007Lee SH, Roh JL, Gong G, Cho KJ, Choi SH, Nam SY, Kim SY. Risk Factors for Recurrence After Treatment of N1b Papillary Thyroid Carcinoma. Ann Surg. 2019 May;269(5):966-971. doi: 10.1097/SLA.0000000000002710.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Cancer, run by Assiut University.
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 4 inclusion and 2 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 20 Feb 2024. 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?
Results are not available in the source record.
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?
Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154863, which also lists 5 linked publications.
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 20 Feb 2024.