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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06134830
Collaborator
(none)
100
25

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Outcome and Quality of Life in Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Outcome Measures

Primary Outcome Measures

  1. The proportion of patients with differentiated thyroid cancer receiving a single dose of RAI. [2 Years]

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

Secondary Outcome Measures

  1. Quality of life score of affected patients will be assessed through validated quality of life questionnaire (SF-36). [2 Years]

    Questionnaire for quality of life in differentiated thyroid cancer patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hager Hamdy Sayed Mohammed, Clinical outcome and quality of life in differentiated thyroid cancer patients treated with different doses of radioactive iodine., Assiut University
ClinicalTrials.gov Identifier:
NCT06134830
Other Study ID Numbers:
  • thyroid cancer and RAI
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023