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Completed

NCT Number: NCT05280379

Trained Immunity in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RadboudUMC

Nijmegen, Gelderland, 6525GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention will take place

Other

no intervention will take place

Primary outcomes

  1. Levels of pro-inflammatory cytokines en chemokines

    Time frame: 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.

Other outcomes

  1. Age of subjects

    Time frame: At baseline

    Age in years of subjects

  2. Length of subjects

    Time frame: At baseline

    Length in meters of subjects

  3. Weight of subjects

    Time frame: Through study completion, an average of 1 year

    Weight in kilograms of subjects

  4. Thyroid stimulating hormone

    Time frame: At baseline

    Levels of thyroid stimulating hormone (TSH), measured in mili unit/Liter. Only measured in the patients with thyroid carcinoma.

  5. Carcino-embryonal antigen

    Time frame: At baseline

    Levels of carcino-embryonal antigen (CEA), measured in ug/Liter. Only measured in patients with colon carcinoma.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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