Trained Immunity in Thyroid Carcinoma and Colon Carcinoma

NCT05280379 | Completed

• 1 other identifier: NL79885.091.21
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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

Colon Carcinoma; Thyroid Cancer, Nonmedullary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Age of subjects

  At baseline

• Length of subjects

  At baseline

• Weight of subjects

  Through study completion, an average of 1 year

Study Arms (2)

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

Participants with colon carcinoma

30 participants with colon carcinoma, who are going to get surgery

Other: no intervention will take place

Interventions

no intervention will take place OTHER

no intervention will take place

Participants with colon carcinoma; Participants with non-medullary thyroid carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 15, 2022
• Study Start: September 19, 2022
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)