Thyroid CancerNCT07056218
Outcome of RAI131 Therapy in Patients With Differentiated Thyroid Cancer (Low and Intermediate Risk)
An observational study of Thyroid Cancer, run by Sohag University.
Trial summary
Thyroid cancer is a universally relatively rare neoplasm, accounting for nearly 1-5% of all female cancers and less than 2% of male cancers. In spite of this relatively low incidence, it occupies the first rank among the most common endocrinal malignancies, with a consistent male to female ratio of 1: 3 observed in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- neck ultrasound and thyroglobulin
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include 50 patients with thyroid cancer.
Who may be able to join
- Pathologically or cytologically proven differentiated thyroid cancer.
- Total thyroidectomy with or without lymph node dissection
- Patient was treated by RAI after surgery
- Male and female patients
- Age >18 yrs
Who cannot join
- 1) Patients with undifferentiated thyroid cancer. 2) patients with high risk (distant metastasis) 3)patient with double malignancy 4) medullary thyroid cancer 4) Patient age < 18 years. 5)patient not treated by surgery or RAI
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Wafaa A Elsayed, assisstant lecturer contact
About this study
Thyroid cancer is a universally relatively rare neoplasm, accounting for nearly 1-5% of all female cancers and less than 2% of male cancers. In spite of this relatively low incidence, it occupies the first rank among the most common endocrinal malignancies, with a consistent male to female ratio of 1: 3 observed in nearly all ethnic groups and geographic areas.
Differentiated thyroid cancer (DTC) is rated as slowly growing disease with a fairly good outcome where the five-year survival rate for localized tumor is 99.8% Total thyroidectomy, the removal of the entire thyroid gland, is the most common surgical approach-especially for tumors larger than 1 cm, multifocal disease, or suspected lymph node involvement. Lobectomy may be considered for small, low-risk tumors (<1 cm) confined to a single lobe. If lymph node metastasis is evident clinically or radiologically, neck dissection is performed. Postoperative radioactive iodine (RAI) therapy is used to ablate residual tissue or treat recurrent disease, particularly in iodine-avid tumors and intermediate- to high-risk patients. It may not be necessary for small, low-risk tumors. Thyroid hormone suppression therapy with levothyroxine serves both to replace thyroid hormone and suppress TSH, which could stimulate cancer growth. Long-term monitoring includes serial thyroglobulin (Tg) levels (along with anti-Tg antibodies if needed), neck ultrasound, and, in some cases, additional imaging like RAI scans or PET/CT to detect recurrence
- Conditions
- Thyroid Cancer
- Being tested
- neck ultrasound, thyroglobulin
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neck ultrasoundDevice
ultrasound scan
thyroglobulinDiagnostic test
blood test
| Study group | Role | What they receive |
|---|---|---|
| low risk | patients typically have intrathyroidal papillary or follicular carcinoma, tumors <4 cm, no lymph node metastasis or only <5 small-volume (<0.2 cm) mico metastases, no vascular invasion (for follicular type), no aggressive histologic features, and no local or distant metastases. Receives: Device: neck ultrasound; Diagnostic Test: thyroglobulin | |
| intermediate risk | includes cases with microscopic extrathyroidal extension (ETE), cervical lymph node metastases (especially >5 nodes or >0.2 cm), vascular invasion, aggressive histologic variants, or RAI-avid distant metastases Receives: Device: neck ultrasound; Diagnostic Test: thyroglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome of radioactive iodine therapy on thyroid cancer
outcome of radioactive iodine therapy on thyroid cancer
Measured: 12:18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ashraf Sabry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056218
- Sponsor's protocol ID
- Soh-Med-25-6-7MS
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Y, Su L, Xiao H. Review of Factors Related to the Thyroid Cancer Epidemic. Int J Endocrinol. 2017;2017:5308635. doi: 10.1155/2017/5308635. Epub 2017 May 2.
PubMed 28555155Baloch ZW, Asa SL, Barletta JA, Ghossein RA, Juhlin CC, Jung CK, LiVolsi VA, Papotti MG, Sobrinho-Simoes M, Tallini G, Mete O. Overview of the 2022 WHO Classification of Thyroid Neoplasms. Endocr Pathol. 2022 Mar;33(1):27-63. doi: 10.1007/s12022-022-09707-3. Epub 2022 Mar 14.
PubMed 35288841Tondi Resta I, Gubbiotti MA, Montone KT, Livolsi VA, Baloch ZW. Differentiated high grade thyroid carcinomas: Diagnostic consideration and clinical features. Hum Pathol. 2024 Feb;144:53-60. doi: 10.1016/j.humpath.2024.01.002. Epub 2024 Jan 19.
PubMed 38244615do Prado Padovani R, Duarte FB, Nascimento C. Current practice in intermediate risk differentiated thyroid cancer - a review. Rev Endocr Metab Disord. 2024 Feb;25(1):95-108. doi: 10.1007/s11154-023-09852-y. Epub 2023 Nov 23.
PubMed 37995023
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of RAI131 Therapy in Patients With Differentiated Thyroid Cancer (Low and Intermediate Risk)
- ClinicalTrials.gov ID
- NCT07056218
- Acronym / sponsor ID
- Soh-Med-25-6-7MS
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Jul 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 a universally relatively rare neoplasm, accounting for nearly 1-5% of all female cancers and less than 2% of male cancers. In spite of this relatively low incidence, it occupies the first rank among the most common endocrinal malignancies, with a consistent male to female ratio of 1: 3 observed in nearly all ethnic groups and geographic areas.
Differentiated thyroid cancer (DTC) is rated as slowly growing disease with a fairly good outcome where the five-year survival rate for localized tumor is 99.8% Total thyroidectomy, the removal of the entire thyroid gland, is the most common surgical approach-especially for tumors larger than 1 cm, multifocal disease, or suspected lymph node involvement. Lobectomy may be considered for small, low-risk tumors (<1 cm) confined to a single lobe. If lymph node metastasis is evident clinically or radiologically, neck dissection is performed. Postoperative radioactive iodine (RAI) therapy is used to ablate residual tissue or treat recurrent disease, particularly in iodine-avid tumors and intermediate- to high-risk patients. It may not be necessary for small, low-risk tumors. Thyroid hormone suppression therapy with levothyroxine serves both to replace thyroid hormone and suppress TSH, which could stimulate cancer growth. Long-term monitoring includes serial thyroglobulin (Tg) levels (along with anti-Tg antibodies if needed), neck ultrasound, and, in some cases, additional imaging like RAI scans or PET/CT to detect recurrence
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low risk | – | Device: neck ultrasound, Diagnostic Test: thyroglobulinpatients typically have intrathyroidal papillary or follicular carcinoma, tumors <4 cm, no lymph node metastasis or only <5 small-volume (<0.2 cm) mico metastases, no vascular invasion (for follicular type), no aggressive histologic features, and no local or distant metastases. |
| intermediate risk | – | Device: neck ultrasound, Diagnostic Test: thyroglobulinincludes cases with microscopic extrathyroidal extension (ETE), cervical lymph node metastases (especially >5 nodes or >0.2 cm), vascular invasion, aggressive histologic variants, or RAI-avid distant metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include 50 patients with thyroid cancer.
Key inclusion criteria (5 listed)
- Pathologically or cytologically proven differentiated thyroid cancer.
- Total thyroidectomy with or without lymph node dissection
- Patient was treated by RAI after surgery
- Male and female patients
- Age >18 yrs
Key exclusion criteria (1 listed)
- 1) Patients with undifferentiated thyroid cancer. 2) patients with high risk (distant metastasis) 3)patient with double malignancy 4) medullary thyroid cancer 4) Patient age < 18 years. 5)patient not treated by surgery or RAI
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 |
|---|---|---|
| neck ultrasoundultrasound scan | Device | intermediate risk, low risk |
| thyroglobulinblood test | Diagnostic test | intermediate risk, low risk |
Primary outcome
outcome of radioactive iodine therapy on thyroid cancer
Time frame: 12:18 months
outcome of radioactive iodine therapy on thyroid cancer
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 9 Jul 2025.
- Background: PubMed 28555155Liu Y, Su L, Xiao H. Review of Factors Related to the Thyroid Cancer Epidemic. Int J Endocrinol. 2017;2017:5308635. doi: 10.1155/2017/5308635. Epub 2017 May 2.
- Background: PubMed 35288841Baloch ZW, Asa SL, Barletta JA, Ghossein RA, Juhlin CC, Jung CK, LiVolsi VA, Papotti MG, Sobrinho-Simoes M, Tallini G, Mete O. Overview of the 2022 WHO Classification of Thyroid Neoplasms. Endocr Pathol. 2022 Mar;33(1):27-63. doi: 10.1007/s12022-022-09707-3. Epub 2022 Mar 14.
- Background: PubMed 38244615Tondi Resta I, Gubbiotti MA, Montone KT, Livolsi VA, Baloch ZW. Differentiated high grade thyroid carcinomas: Diagnostic consideration and clinical features. Hum Pathol. 2024 Feb;144:53-60. doi: 10.1016/j.humpath.2024.01.002. Epub 2024 Jan 19.
- Background: PubMed 37995023do Prado Padovani R, Duarte FB, Nascimento C. Current practice in intermediate risk differentiated thyroid cancer - a review. Rev Endocr Metab Disord. 2024 Feb;25(1):95-108. doi: 10.1007/s11154-023-09852-y. Epub 2023 Nov 23.
- Individual participant dataSharing planned: Undecided
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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.
Wafaa A Elsayed, assisstant lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Sohag 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 5 inclusion and 1 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 9 Jul 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?
Contact Rana A Sabry, resident (01008706603, rana.ashraf@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome of radioactive iodine therapy on thyroid cancer (time frame: 12:18 months). 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 NCT07056218, which also lists 4 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 9 Jul 2025.