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van CCT (UK)

van CCT (UK)

Myeloid cell reprogramming in thyroid carcinoma

- candidate number27586
- NTR NumberNTR7003
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jul-2017
- Secondary IDs2017-3628 NL62671.091.17
- Public TitleMyeloid cell reprogramming in thyroid carcinoma
- Scientific TitleMyeloid cell reprogramming in the context of radioiodine therapy in patients with non-medullary thyroid carcinoma
- hypothesis1. We first propose that in advanced TC, not only tumor-associated macrophages (TAMs), but also circulating monocytes and bone marrow (BM) myeloid progenitors are functionally reprogrammed by tumor-derived metabolites even before their recruitment in the TME.
2. Radioactive iodide (I131)(RAI) is a very effective therapy for patients with TC, but is less effective in patients with advanced, metastatic tumors. We hypothesize that by exposing tumor antigens to the immune system, RAI might induce immunogenic effects at the level of the TME with reprogramming of both TAMs present in the TME and circulating monocytes, towards a tumor suppressive phenotype. This may further potentiate the effects of RAI. In addition this could be explored in the future as a basis for immunotherapy for tumors that are refractory to conventional treatment.
- Healt Condition(s) or Problem(s) studiedThyroid carcinoma
- Inclusion criteriaIn 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 na´ve 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 na´ve 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)
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 criteriaA 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2017
- planned closingdate
- Target number of participants50
- InterventionsNot applicable.
- Primary outcomeTranscriptional and epigenetic signature and function of TAMs, BM myeloid progenitors and circulating macrophages before and after treatment.
- Secondary outcomePresence 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.
- Timepoints-before treatment
-30 days after surgery
-7days after RAI treatment
-30days after RAI treatment
- Trial web site
- status[default]
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summary
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD25-jul-2017 - 8-feb-2018

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