Thyroid Cancer, NonmedullaryNCT05280379
Trained Immunity in Thyroid Carcinoma and Colon Carcinoma
An observational study of Thyroid Cancer, Nonmedullary and Colon Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Tumor-related inflammation is one of the hallmarks of cancers in general. Innate immunity specifically is a common denominator which is involved in the pathogenesis of both thyroid carcinoma and colon carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Nonmedullary, Colon Carcinoma
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2022to 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: The study population consists of 30 participants with active colon carcinoma and 30 participants with active non-medullary thyroid carcinoma. All participants will undergo surgery.
Who may be able to join
- At least 18 years old and mentally competent
- Newly diagnoses non-medullary thyroid carcinoma or colon carcinoma that is therapy naïve
- Planned to receive conventional treatment for the malignancy by surgery
Who cannot join
- Mentally incompetent
- Pregnant or breastfeeding
- Known inflammation or infectious disease or an immunosuppressive status
- Using medication interfering with the immune system
- Reduced platelets counts or other conditions associated with an increased risk of bleeding
- Severe comorbidities: other active malignancy (except for basal cell carcinoma and other in situ carcinomas)
Show all 9Show fewer
- Previous anti-cancer treatment, such as chemotherapy, radiotherapy or surgical removal or the primary tumor
- Serious psychiatric pathology
- A self-reported alcohol consumption of >21 units per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trained Immunity of Myeloid Cells and Their Progenitors in Patients With Non-medullary Thyroid Carcinoma and Colon Carcinoma
Tumor-related inflammation is one of the hallmarks of cancers in general. Innate immunity specifically is a common denominator which is involved in the pathogenesis of both thyroid carcinoma and colon carcinoma. To improve the patient's outcome and identify novel therapeutic targets, one needs a deeper understanding of the tumor-induced changes in the bone marrow myeloid progenitor cells. Furthermore, treatment of these cells by nanoparticles or other agents that induce a program of 'trained immunity' may be a novel way to re-educate myeloid cells and their bone marrow progenitors in thyroid carcinoma patients. Lastly, the investigators expect that this approach could be effective also in other cancers of which colon carcinoma is here proposed as an additional model.
The investigators hypothesize that by exposing myeloid cells or their progenitors to various agents that induce trained immunity (e.g. high-density-lipoprotein-methylene diphosphonate nanoparticles, recombinant and synthetic cytokines), these immune cells will undergo functional reprogramming to induce a tumor-suppressive phenotype. In the future, this could be explored as a novel immunotherapy for tumors that are refractory to conventional treatment.
- Conditions
- Thyroid Cancer, Nonmedullary, Colon Carcinoma
- Being tested
- no intervention will take place
- Medical subject headings
- Thyroid Cancer, Papillary, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention will take placeOther
no intervention will take place
| Study group | Role | What they receive |
|---|---|---|
| Participants with non-medullary thyroid carcinoma | 30 patients with non-medullary thyroid carcinoma, who are going to get surgery Receives: Other: no intervention will take place | |
| Participants with colon carcinoma | 30 participants with colon carcinoma, who are going to get surgery Receives: Other: no intervention will take place |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of pro-inflammatory cytokines en chemokines
Levels of pro-inflammatory cytokines en chemokines such as tumor necrosis factor-alfa,interleukin(IL)-1beta and IL-6 will be measured (pg/miliLiter) before and after induction of trained immunity. This will happen after 1 and after 7 days. These will be measured using ELISA.
Measured: After 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start19 Sep 2022
- Primary completion1 May 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer, 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
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
- NCT05280379
- Sponsor's protocol ID
- NL79885.091.21
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trained Immunity of Myeloid Cells and Their Progenitors in Patients With Non-medullary Thyroid Carcinoma and Colon Carcinoma
- ClinicalTrials.gov ID
- NCT05280379
- Acronym / sponsor ID
- NL79885.091.21
- Conditions
- Thyroid Cancer, Nonmedullary, Colon Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Mar 2022 (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.
Tumor-related inflammation is one of the hallmarks of cancers in general. Innate immunity specifically is a common denominator which is involved in the pathogenesis of both thyroid carcinoma and colon carcinoma. To improve the patient's outcome and identify novel therapeutic targets, one needs a deeper understanding of the tumor-induced changes in the bone marrow myeloid progenitor cells. Furthermore, treatment of these cells by nanoparticles or other agents that induce a program of 'trained immunity' may be a novel way to re-educate myeloid cells and their bone marrow progenitors in thyroid carcinoma patients. Lastly, the investigators expect that this approach could be effective also in other cancers of which colon carcinoma is here proposed as an additional model.
The investigators hypothesize that by exposing myeloid cells or their progenitors to various agents that induce trained immunity (e.g. high-density-lipoprotein-methylene diphosphonate nanoparticles, recombinant and synthetic cytokines), these immune cells will undergo functional reprogramming to induce a tumor-suppressive phenotype. In the future, this could be explored as a novel immunotherapy for tumors that are refractory to conventional treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with non-medullary thyroid carcinoma | – | Other: no intervention will take place30 patients with non-medullary thyroid carcinoma, who are going to get surgery |
| Participants with colon carcinoma | – | Other: no intervention will take place30 participants with colon carcinoma, who are going to get surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 30 participants with active colon carcinoma and 30 participants with active non-medullary thyroid carcinoma. All participants will undergo surgery.
Key inclusion criteria (3 listed)
- At least 18 years old and mentally competent
- Newly diagnoses non-medullary thyroid carcinoma or colon carcinoma that is therapy naïve
- Planned to receive conventional treatment for the malignancy by surgery
Key exclusion criteria (9 listed)
- Mentally incompetent
- Pregnant or breastfeeding
- Known inflammation or infectious disease or an immunosuppressive status
- Using medication interfering with the immune system
- Reduced platelets counts or other conditions associated with an increased risk of bleeding
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 |
|---|---|---|
| no intervention will take placeno intervention will take place | Other | Participants with colon carcinoma, Participants with non-medullary thyroid carcinoma |
Primary outcome
Levels of pro-inflammatory cytokines en chemokines
Time frame: After 7 days.
Levels of pro-inflammatory cytokines en chemokines such as tumor necrosis factor-alfa,interleukin(IL)-1beta and IL-6 will be measured (pg/miliLiter) before and after induction of trained immunity. This will happen after 1 and after 7 days. These will be measured using ELISA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, Nonmedullary and Colon Carcinoma, 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 9 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of pro-inflammatory cytokines en chemokines (time frame: After 7 days.). 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 9 Dec 2025.