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Myeloid cell reprogramming in thyroid carcinoma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21311
Enrollment
50
Registered
2017-07-25
Start date
2017-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid carcinoma

Interventions

Not applicable.

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: In general: Subjects should be at least 18 years old and mentally competent Patients with TC: 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) -at least 4 months since the previous treatment with RAI (in the patients who have had this treatment in the past) Controls: Group 3: -patients with MNG that are euthyroid and in which the decision has been taken to undergo surgery because of obstructive symptoms or for cosmetic reasons Group 4: -patients with MNG that are euthyroid and in which the decision has been taken to undergo RAI because of obstructive symptoms. Group 5: -healthy individuals who are euthyroid and have no evidence of thyroid disease.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: -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

Design outcomes

Primary

MeasureTime frame
Transcriptional and epigenetic signature and function of TAMs, BM myeloid progenitors and circulating macrophages before and after treatment.

Secondary

MeasureTime frame
Presence of circulating tumor cells (CTC) and changes in circulating metabolites (either tumor-derived or tumor-induced) concentrations (metabolomics) associated with the functional reprogramming of the immune cells.

Contacts

Public ContactWanda Raadt, de

PO Box 30016

w.deraadt@uroweb.org+31 (0)26 3890677

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)