Clinical trial NCT04133870: Identification of Molecular Biomarkers for Thyroid Cancer
Official title: Exploratory Study of the Molecular Profile of Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a biological study to obtain tissue and blood samples from patients with advanced thyroid cancer

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* T3-4, N0-1b, M0-M1 thyroid cancer (papillary, follicular, poorly differentiated, anaplastic and medullary thyroid carcinoma).
* Patient able to provide informed consent
* Patient attending the Royal Marsden Hospital for inpatient or outpatient review
* Sufficient tissue sample available to perform analysis (archived or fresh)
* Adults \>16 years old

Exclusion Criteria:

* Patients unable to provide informed consent
* Thyroid lymphoma
* Metastases to the thyroid
* No histological confirmed diagnosis
* Only cytology available

Primary outcomes:
measure: Primary Objective
timeFrame: 3 Years (at the end of study)
measure: Primary Objective
timeFrame: 3 years (at end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Sutton
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Kate Newbold
role: PRINCIPAL_INVESTIGATOR
References: