Identification of Molecular Biomarkers for Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Exploratory Study of the Molecular Profile of Thyroid Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04133870
• Other study ID #: CCR4343
• Status: Active, not recruiting
• Start date: December 21, 2015
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2018
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: July 30, 2020
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	London	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	Part A: blood and tumour tissue will be measured to determine molecular profiling.	3 Years (at the end of study)
Primary	Primary Objective	Part B: blood and tumour tissue will be assessed to establish cell lines and to determine patient derived xenograft (PDX) models of thyroid cancer	3 years (at end of study)