Trained Immunity in Thyroid Carcinoma and Colon Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Colon Carcinoma; Thyroid Cancer, Nonmedullary
• Intervention / Treatment: Other: no intervention will take place

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with non-medullary thyroid carcinoma; 30 patients with non-medullary thyroid carcinoma, who are going to get surgery	Other: no intervention will take place; no intervention will take place
Participants with colon carcinoma; 30 participants with colon carcinoma, who are going to get surgery	Other: no intervention will take place; no intervention will take place

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 7 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of subjects	Age in years of subjects	At baseline
Length of subjects	Length in meters of subjects	At baseline
Weight of subjects	Weight in kilograms of subjects	Through study completion, an average of 1 year
Thyroid stimulating hormone	Levels of thyroid stimulating hormone (TSH), measured in mili unit/Liter. Only measured in the patients with thyroid carcinoma.	At baseline
Carcino-embryonal antigen	Levels of carcino-embryonal antigen (CEA), measured in ug/Liter. Only measured in patients with colon carcinoma.	At baseline

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Colonic Diseases; Carcinoma; Thyroid Diseases; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Colonic Neoplasms
• Other Study ID Numbers: NL79885.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No