Myeloid cell reprogramming in the context of radioiodine therapy in patients with non-medullary thyroid carcinoma

Completed

Conditions: thyroid carcinoma
10014713

Registration Number: NL-OMON48852

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Group 1:
-newly diagnosed patients with TC that are therapy naïve and are planned to
receive conventional treatment by surgery followed by RAI.
-no evidence of local or distant metastases
Group 2:
-patients with TC with evidence of distant metastases (either newly diagnosed
patients who are therapy naïve or patients with persistent or recurrent
disease) and are planned to receive conventional treatment by surgery followed
by RAI.
-at least 4 months since the previous treatment with RAI (in the patients who
have had this treatment in the past)
Group 3:
-patients with MNG in which the decision has been taken to undergo surgery
because of obstructive symptoms or for cosmetic reasons
Group 4:
-patients with MNG in which the decision has been taken to undergo RAI because
of obstructive symptoms.
Group 5:
-healthy individuals without evidence of thyroid disease.

Exclusion Criteria

Excluded from participation in this study will be subjects who are/have:
Mentally incompetent;
Pregnant or breastfeeding;
Known inflammatory or infectious diseases 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), serious psychiatric pathology;
A self-reported alcohol consumption of >21 units per week.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Transcriptional and epigenetic signature and function of TAMs, BM myeloid<br /><br>progenitors and circulating macrophages before and after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Presence of circulating tumor cells (CTC) and changes in circulating<br /><br>metabolites (either tumor-derived or tumor-induced) concentrations<br /><br>(metabolomics) associated with the functional reprograming of the immune cells.</p><br>