Thyroid Cancer Clinical Trial
Official title:
Exploratory Study of the Molecular Profile of Thyroid Cancer
This is a two part study; part A proposes to collect plasma samples to examine how ctDNA (circulating thyroid DNA) markers correlate with detection of recurrent disease, response to therapy, clinical outcome and pathological data. Part B aims to use tissue obtained from biopsies of primary or recurrent disease to establish cell lines and tumour explants to further investigate the biology of thyroid cancer in the preclinical setting
To collect blood and tumour tissue for Part A: molecular profiling, including extraction of
DNA for sequencing, RNA for expression levels and to identify expressed fusion genes, and
proteins for proteomic studies and Part B: for establishment of cell lines and patient
derived xenograft (PDX) models of thyroid cancer.
1. To correlate BRAF V600E, RAS, RET/PTC, RET, PAX8/PPARϒ, βcatenin, p53, PTEN and PI3K
mutations in ctDNA with Formalin Fixed Paraffin Embedded tumour tissue (FFPE) mutational
analysis.
2. To correlate the quantity of ctDNA fragments 3 monthly in patients with advanced disease
on routine follow up with conventional tumour markers (Tg, calcitonin, CEA).
3. To correlate the quantity of ctDNA fragments 3 monthly once relapse suspected by
conventional methods (Tg, Calcitonin, CEA, radiological)
4. To correlate the quantity of ctDNA fragments with response (RECIST, Tg, Calcitonin and
CEA) to targeted therapies
5. To assess prognostic significance of ctDNA levels in metastatic/advanced thyroid cancer
6. To isolate live tumor cells for studies of novel treatment strategies (combinatorial
treatments), therapy resistance and thyroid cancer biology
7. Retrieval and analysis of archival primary tissue blocks for comparison with metastatic
tumour sites
8. To collect blood for analysis of noninvasive tests of tumour phenotype
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