Thyroid Carcinoma, NonmedullarySCIMITARNCT05989555
Effects of Radioactive Iodine on the Immune System in Thyroid Cancer
An observational study of Thyroid Carcinoma, Nonmedullary, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Blood will be drawn 1 month before and 2 month after regular radioactive iodine treatment. Monocytes will be isolated. The three main outcomes are whole blood counts, cytokine production upon in vitro stimulation of monocytes and in vitro ROS production by monocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma, Nonmedullary
- What is being tested?
- Blood drawing
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Thirty patients with non-medulary thyroid carcinoma
Who may be able to join
- Pathologically confirmed non-medullary thyroid cancer
- Undergoing radioactive iodine treatment in an adjuvant setting or for persistent structural disease
- Aged ≥ 18 years
Who cannot join
- Inflammatory or infectious comorbidities
- Using medication interfering with the immune system
- Pregnancy
- A self-reported alcohol consumption of >21 units per week
- Other active malignancies, defined as malignancies not in complete remission for <2 years
- Previous systemic anti-cancer treatment such as chemotherapy, targeted therapy, radiotherapy or immunotherapy within 3 years before study procedures
Trial locations and contacts
1 site in 1 country.
Prashant Changoer, Msc. contact
Netherlands1 site
Radboud University Medical Center
Nijmegen
Pepijn van Houten, Msc., +31-24-3614599, pepijn.vanhouten@radboudumc.nl
About this study
Official title: Effects on the Systemic Innate Immune System by Radioactive Iodine Treatment in Non-medullary Thyroid Cancer Patients
Blood will be drawn 1 month before and 2 month after regular radioactive iodine treatment. Monocytes will be isolated. The three main outcomes are whole blood counts, cytokine production upon in vitro stimulation of monocytes and in vitro ROS production by monocytes. These results are compared between patients treated in adjuvant setting and patients treated for persistent structural disease, and between pre- and post-treatment status.
Read the detailed description
Earlier studies have shown that, particularly advanced, thyroid carcinomas are highly immunogenic tumors. The immune system is involved in both pathogenesis and progression of thyroid carcinoma (TC), as in other malignancies. For example, it is known that increased tumor infiltration with tumor-associated macrophages is associated with decreased survival in TC patients. In a previous study from our group, changes in the programming of myeloid immune cells were identified in newly diagnoses TC patients. That study showed that upon stimulation, cytokine production was decreased in monocytes from TC patients when compared to monocytes from healthy volunteers or from patients with benign thyroid tumors. Also, reactive oxygen species (ROS) production (known to be tumorigenic) from monocytes was increased in TC patients when compared to healthy volunteers. In the mentioned study, several effects of radioactive iodine (RAI)-treatment, after surgery, on the systemic immune system were observed. For instance, lymphocyte counts were significantly reduced after treatment with RAI, an effect also observed in other studies. Moreover, after RAI-treatment, ROS levels produced by monocytes decreased to levels similar to those produced by monocytes of healthy controls. Although, the effect of RAI-treatment on ROS-production was less pronounced than that of surgery. There was no clear effect of RAI-treatment on the cytokine production capacity. However, it should be noted that in most patients in this study RAI was administered in a setting of remnant ablation, meaning that only a low dose of RAI was administered and that only a very low amount (or none) of cancer cells were present at the time of administration. Furthermore, the number of included patients was too low to perform subgroup analyses. The current study aims to assess the effect of RAI-treatment in patients with structural disease, as a higher dose of beta-radiation will be present in these patients, and compare these effects to that in patients treated with RAI in an adjuvant setting.
The investigators hypothesize that RAI-treatment will have a more pronounced effect on the systemic innate immune system in patients with structural disease when compared to patients treated in an adjuvant setting. This study will give us more insights in the interplay between RAI and the immune system in patients with TC.
The aim of the study is to assess the effect of RAI-treatment on the innate immune system in TC patients and to compare these effects between patients with and without structural disease in a prospective explorative study.
- Conditions
- Thyroid Carcinoma, Nonmedullary
- Being tested
- Blood drawing
- Keywords
- radioactive iodine, innate immune system, monocytes
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawingOther
Blood is drawn twice in all subjects. Once before treatment with radioacitve iodine and once after.
| Study group | Role | What they receive |
|---|---|---|
| I/adjuvant | 15 patients with thyroid carcinoma that are treated with radioacitive iodine in an adjuvant setting Receives: Other: Blood drawing | |
| II/structutral disease | 15 patients with thyroid carcinoma that are treated with radioactive iodine with the indication of persistent structural disease Receives: Other: Blood drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood counts
Whole blood counts with leukocyte subtypes (neutrophils, lymphocytes and monocytes) are compared before and after radioactive iodine treatment
Measured: 2 months
Cytokine production upon monocyte stimulation
Cytokine produciton (tumor necrosis factor, interleukin-6, interleukin-8) will be compared before and after treatment with radioactive iodine
Measured: 2 months
Reactive oxygen species (ROS) production by monocytes
In vitro ROS production by monocytes will be compared before and after treatment with radioactive iodine
Measured: 2 months
Secondary outcomes (2)
Monocyte transcriptome
Possibly, transcriptome of monocytes will be compared before and after treatment with radioactive iodine
Measured: 2 months
Plasma proteome
Possibly, plasma proteome (especially inflammatory markers) will be compared before and treatment with radioactive iodine.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Carcinoma, NonmedullaryStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989555
- Sponsor's protocol ID
- 2023-16623
- Other IDs
- 2023
- Acronym
- SCIMITAR
- Status last verified
- Nov 2023
- First submitted
- 4 Aug 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Systemic Innate Immune System by Radioactive Iodine Treatment in Non-medullary Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT05989555
- Acronym / sponsor ID
- SCIMITAR / 2023-16623
- Conditions
- Thyroid Carcinoma, Nonmedullary
- Keywords
- radioactive iodine, innate immune system, monocytes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
Blood will be drawn 1 month before and 2 month after regular radioactive iodine treatment. Monocytes will be isolated. The three main outcomes are whole blood counts, cytokine production upon in vitro stimulation of monocytes and in vitro ROS production by monocytes. These results are compared between patients treated in adjuvant setting and patients treated for persistent structural disease, and between pre- and post-treatment status.
Detailed description
Earlier studies have shown that, particularly advanced, thyroid carcinomas are highly immunogenic tumors. The immune system is involved in both pathogenesis and progression of thyroid carcinoma (TC), as in other malignancies. For example, it is known that increased tumor infiltration with tumor-associated macrophages is associated with decreased survival in TC patients. In a previous study from our group, changes in the programming of myeloid immune cells were identified in newly diagnoses TC patients. That study showed that upon stimulation, cytokine production was decreased in monocytes from TC patients when compared to monocytes from healthy volunteers or from patients with benign thyroid tumors. Also, reactive oxygen species (ROS) production (known to be tumorigenic) from monocytes was increased in TC patients when compared to healthy volunteers. In the mentioned study, several effects of radioactive iodine (RAI)-treatment, after surgery, on the systemic immune system were observed. For instance, lymphocyte counts were significantly reduced after treatment with RAI, an effect also observed in other studies. Moreover, after RAI-treatment, ROS levels produced by monocytes decreased to levels similar to those produced by monocytes of healthy controls. Although, the effect of RAI-treatment on ROS-production was less pronounced than that of surgery. There was no clear effect of RAI-treatment on the cytokine production capacity. However, it should be noted that in most patients in this study RAI was administered in a setting of remnant ablation, meaning that only a low dose of RAI was administered and that only a very low amount (or none) of cancer cells were present at the time of administration. Furthermore, the number of included patients was too low to perform subgroup analyses. The current study aims to assess the effect of RAI-treatment in patients with structural disease, as a higher dose of beta-radiation will be present in these patients, and compare these effects to that in patients treated with RAI in an adjuvant setting.
The investigators hypothesize that RAI-treatment will have a more pronounced effect on the systemic innate immune system in patients with structural disease when compared to patients treated in an adjuvant setting. This study will give us more insights in the interplay between RAI and the immune system in patients with TC.
The aim of the study is to assess the effect of RAI-treatment on the innate immune system in TC patients and to compare these effects between patients with and without structural disease in a prospective explorative study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I/adjuvant | – | Other: Blood drawing15 patients with thyroid carcinoma that are treated with radioacitive iodine in an adjuvant setting |
| II/structutral disease | – | Other: Blood drawing15 patients with thyroid carcinoma that are treated with radioactive iodine with the indication of persistent structural disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients with non-medulary thyroid carcinoma
Key inclusion criteria (3 listed)
- Pathologically confirmed non-medullary thyroid cancer
- Undergoing radioactive iodine treatment in an adjuvant setting or for persistent structural disease
- Aged ≥ 18 years
Key exclusion criteria (6 listed)
- Inflammatory or infectious comorbidities
- Using medication interfering with the immune system
- Pregnancy
- A self-reported alcohol consumption of >21 units per week
- Other active malignancies, defined as malignancies not in complete remission for <2 years
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 |
|---|---|---|
| Blood drawingBlood is drawn twice in all subjects. Once before treatment with radioacitve iodine and once after. | Other | I/adjuvant, II/structutral disease |
Primary outcome
Whole blood counts
Time frame: 2 months
Whole blood counts with leukocyte subtypes (neutrophils, lymphocytes and monocytes) are compared before and after radioactive iodine treatment
Cytokine production upon monocyte stimulation
Time frame: 2 months
Cytokine produciton (tumor necrosis factor, interleukin-6, interleukin-8) will be compared before and after treatment with radioactive iodine
Reactive oxygen species (ROS) production by monocytes
Time frame: 2 months
In vitro ROS production by monocytes will be compared before and after treatment with radioactive iodine
2 secondary outcomes
Monocyte transcriptome
Time frame: 2 months
Plasma proteome
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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. This study is not recruiting at the moment.
Prashant Changoer, Msc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Carcinoma, Nonmedullary, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pepijn van Houten, M.D. (+31243614599, pepijn.vanhouten@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole blood counts (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.