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AzTrials

Thyroid CancerNCT06134830

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

An observational study of Thyroid Cancer, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Thyroid Cancer
What is being tested?
RAI
How many people
100 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Jan 2027
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: Patients with differentiated cancer thyroid treated at Assiut University Hospitals.

Who may be able to join

  • • Patients with differentiated cancer thyroid either papillary or follicular underwent total thyroidectomy with or without lymph node dissection.
  • Available data of patients' records.

Who cannot join

  • • Missed follow up data.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hager Hamdy, Master contact

01159047417

hagham669@gmail.com

Hoda Hassan contact

01001732757

hodahassanessa@yahoo.com

About this study

Official title: Clinical Outcome and Quality of Life in 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.
Read the 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.

Conditions
Thyroid Cancer
Being tested
RAI
Medical subject headings
Thyroid Neoplasms

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.

  1. 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.

    Measured: 2 Years

Secondary outcomes (1)

  1. 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.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134830
Sponsor's protocol ID
thyroid cancer and RAI
Status last verified
Feb 2024
First submitted
13 Nov 2023
Last updated
6 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34981741

  • 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.

    PubMed 28868259

  • 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.

    PubMed 16728537

  • 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.

    PubMed 26462967

Questions about this trial

What is this clinical trial studying?

An observational study of 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 2 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 6 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?

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 Hager Hamdy, Master (01159047417, hagham669@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with differentiated thyroid cancer receiving a single dose of RAI. (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 NCT06134830, 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 6 Feb 2024.

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