Trained Immunity in Thyroid Carcinoma and Colon Carcinoma

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05280379
Collaborator
(none)
60
1
32
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention will take place

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Trained Immunity of Myeloid Cells and Their Progenitors in Patients With Non-medullary Thyroid Carcinoma and Colon Carcinoma
Actual Study Start Date :
Aug 7, 2022
Anticipated Primary Completion Date :
Apr 7, 2024
Anticipated Study Completion Date :
Apr 7, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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
no intervention will take place

Outcome Measures

Primary Outcome Measures

  1. 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.

Other Outcome Measures

  1. Age of subjects [At baseline]

    Age in years of subjects

  2. Length of subjects [At baseline]

    Length in meters of subjects

  3. Weight of subjects [Through study completion, an average of 1 year]

    Weight in kilograms of subjects

  4. Thyroid stimulating hormone [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 [At baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 RadboudUMC Nijmegen Gelderland Netherlands 6525GA

Sponsors and Collaborators

  • Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT05280379
Other Study ID Numbers:
  • NL79885.091.21
First Posted:
Mar 15, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022