Trained Immunity in Thyroid Carcinoma and Colon Carcinoma

Recruiting

• Conditions: Thyroid Cancer, Nonmedullary; Colon Carcinoma
• Interventions: Other: no intervention will take place

• Registration Number: NCT05280379
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-13
• Study First Posted: 2022-03-15
• Study Start: 2022-09-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-09-07
• Study Completion: 2025-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with non-medullary thyroid carcinoma	no intervention will take place	30 patients with non-medullary thyroid carcinoma, who are going to get surgery
Participants with colon carcinoma	no intervention will take place	30 participants with colon carcinoma, who are going to get surgery

Primary Outcome Measures

Name	Time	Method
Levels of pro-inflammatory cytokines en chemokines	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.

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands