Trained Immunity in Thyroid Carcinoma and Colon Carcinoma

Colon Carcinoma Clinical Trial

Official title:

Trained Immunity of Myeloid Cells and Their Progenitors in Patients With Non-medullary Thyroid Carcinoma and Colon Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280379
• Other study ID #: NL79885.091.21
• Status: Recruiting
• Start date: September 19, 2022
• Est. completion date: April 7, 2025

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 7, 2025
• Est. primary completion date: September 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colon Carcinoma
• Colonic Neoplasms
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• no intervention will take place
no intervention will take place

Locations

Country	Name	City	State
Netherlands	RadboudUMC	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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