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NCT Number: NCT06134830

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RAI

Drug

Radioactive iodine

Primary outcomes

  1. The proportion of patients with differentiated thyroid cancer receiving a single dose of RAI.

    Time frame: 2 Years

    Proportion of differentiated thyroid cancer patients treated with single dose of RAI.

Secondary outcomes

  1. Quality of life score of affected patients will be assessed through validated quality of life questionnaire (SF-36).

    Time frame: 2 Years

    Questionnaire for quality of life in differentiated thyroid cancer patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Hager Hamdy, Master

CONTACT

[email protected]

01159047417

Hoda Hassan

CONTACT

[email protected]

01001732757

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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