Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.

Thyroid Cancer Clinical Trial

Official title:

Clinical Outcome and Quality of Life in Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06134830
• Other study ID #: thyroid cancer and RAI
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Hager Hamdy, Master
• Phone: 01159047417
• Email: hagham669[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Determine the frequency of utilizing single and multiple doses of radioactive iodine (RAI) in treatment of differentiated thyroid cancer.

2. Asses the impact of various doses of radioactive iodine on the management of differentiated thyroid cancer.

3. Investigate the influence of thyroid cancer on the quality of life of affected patients.

Description:

Differentiated thyroid cancer represents more than 90% of cancer thyroid [1]. Total thyroidectomy is considered the mainstay of curative therapy, with radioactive iodine (RAI) in order to ablate or treat remnant thyroid tissue in the surgical bed and/or elsewhere [2]. The two main objectives for treatment of differentiated cancer thyroid are reducing the probability of cancer recurrence and facilitating serological surveillance via thyroglobulin (TG). The 2015 American Thyroid Association (ATA) guidelines as well as European Consensus Conference described three main risk stratification for thyroid cancer including: low, intermediate and high risk [3] [4]. According to the 2015 ATA guidelines, low- dose (1110 MBq) 131I ablation is recommended for low-to- intermediate-risk patients, while high-dose (3700 MBq or more) 131I ablation may be required for high-risk patients to remove microscopic residual disease(4). The optimal RAI activity needed to achieve the best objective RAI response and to minimize RAI specific adverse effects is not known since there are many factors that should be considered while determining the dose including age of the patient and many pathological factors [5, 6]. Therefore, dose adjustment might be needed for patients with same risk classification. Just following the guidelines might not be optimal for treatment of individual differentiated thyroid cancer [5]. Accordingly, in our centre the administrated activities are varied among our clinicians. In this study, we aim to retrospective analyse patients with differentiated thyroid cancer received variable (single and multiple) doses of RAI in each risk group and to assess their clinical outcome. As thyroid cancer has a very good prognosis, there a debate that quality of life may be affected in patients with high risk compared to low and intermediate risks. Additionally, we intend to evaluate the impact of thyroid cancer on quality of life by questionnaire filled by patients with different risk groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2027
• Est. primary completion date: December 1, 2026
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• • Patients with differentiated cancer thyroid either papillary or follicular underwent total thyroidectomy with or without lymph node dissection.

• Available data of patients' records.

Exclusion Criteria:

• • Missed follow up data.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• RAI
Radioactive iodine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Andresen NS, Buatti JM, Tewfik HH, Pagedar NA, Anderson CM, Watkins JM. Radioiodine Ablation following Thyroidectomy for Differentiated Thyroid Cancer: Literature Review of Utility, Dose, and Toxicity. Eur Thyroid J. 2017 Jul;6(4):187-196. doi: 10.1159/000468927. Epub 2017 Mar 23. — View Citation

Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020. — View Citation

Pacini F, Fuhrer D, Elisei R, Handkiewicz-Junak D, Leboulleux S, Luster M, Schlumberger M, Smit JW. 2022 ETA Consensus Statement: What are the indications for post-surgical radioiodine therapy in differentiated thyroid cancer? Eur Thyroid J. 2022 Jan 1;11(1):e210046. doi: 10.1530/ETJ-21-0046. — View Citation

Pacini F, Schlumberger M, Dralle H, Elisei R, Smit JW, Wiersinga W; European Thyroid Cancer Taskforce. European consensus for the management of patients with differentiated thyroid carcinoma of the follicular epithelium. Eur J Endocrinol. 2006 Jun;154(6):787-803. doi: 10.1530/eje.1.02158. No abstract available. Erratum In: Eur J Endocrinol. 2006 Aug;155(2):385. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with differentiated thyroid cancer receiving a single dose of RAI.	Proportion of differentiated thyroid cancer patients treated with single dose of RAI.	2 Years
Secondary	Quality of life score of affected patients will be assessed through validated quality of life questionnaire (SF-36).	Questionnaire for quality of life in differentiated thyroid cancer patients.	2 Years