Myeloid Cell Reprogramming in Thyroid Carcinoma

NCT03397238 | Completed

• 2 other identifiers: NL62671.091.172017-3628
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the reprogramming of myeloid cells in patients with thyroid carcinoma. The investigators hypothesize that tumor-derived factors change the function of myeloid cells (peripheral blood and bone marrow-derived) in such a way that these immune cells promote tumor growth rather than combat the tumor.

Conditions

Thyroid Cancer

Keywords

myeloid cell; reprogramming; monocyte; tumor-associated macrophage

Outcome Measures

Primary Outcomes (3)

• Transcriptional reprogramming of myeloid cells

  RNAseq

  baseline

• Epigenetic reprogramming of myeloid cells

  ATAC-seq

  baseline

• Functional reprogramming of myeloid cells

  Cytokine response

  baseline

Secondary Outcomes (2)

• Metabolites

  baseline

• Change of reprogramming after RAI treatment

  baseline and 7 days after RAI treatment

Study Arms (5)

Non-metastatic TC

blood withdrawal, bone marrow aspiration

Metastatic TC

blood withdrawal, bone marrow aspiration

MNG surgery

blood withdrawal, bone marrow aspiration

MNG RAI treatment

blood withdrawal

Healthy volunteers

blood withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Group 1:
• Subject is newly diagnosed with TC, therapy-naive and is planned to receive conventional treatment by surgery followed by RAI; no evidence of local or distant metastases
• Group 2:
• Subject has TC with evidence of distant metastases (either newly diagnosed or therapy-naive or patients with persistent or recurrent disease); at least 4 months since the previous treatment with RAI if applicable
• Group 3:
• Subject is diagnosed with MNG, is euthyroid, and is planned to undergo surgery - Group 4: Subject is diagnosed with MNG, is euthyroid, and is planned to receive RAI treatment
• \- Group 5: Healthy individuals who are euthyroid and have no evidence of thyroid disease

You may not qualify if:

• Mentally incompetent
• Pregnant, trying to become pregnant or breastfeeding
• Known inflammatory or infectious diseases or an immunosuppressive status
• Using medication interfering with the immune system
• Reduced platelet counts or other conditions associated with an increased risk of bleeding
• Severe comorbidities: other active malignancy (except for basal cell carcinoma)
• Serious psychiatric pathology
• A self-reported alcohol consumption of \>21 units per week

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Romana T Netea-Maier

  Endocrinologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 11, 2018
• Study Start: March 6, 2018
• Primary Completion: November 26, 2019
• Study Completion: January 5, 2021
• Last Updated: February 9, 2022

Record last verified: 2020-11

Locations

NL (1)