Clinical trial NCT05280379: Trained Immunity in Thyroid Carcinoma and Colon Carcinoma
Official title: Trained Immunity of Myeloid Cells and Their Progenitors in Patients With Non-medullary Thyroid Carcinoma and Colon Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer, Nonmedullary
Colon Carcinoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Levels of pro-inflammatory cytokines en chemokines
timeFrame: After 7 days.
Secondary outcomes:
Other outcomes:
measure: Age of subjects
timeFrame: At baseline
measure: Length of subjects
timeFrame: At baseline
measure: Weight of subjects
timeFrame: Through study completion, an average of 1 year
measure: Thyroid stimulating hormone
timeFrame: At baseline
measure: Carcino-embryonal antigen
timeFrame: At baseline
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
Study officials:
References: