Investigating Utility of ctDNA and Tumour Evolution in Advanced Thyroid Cancer

NCT05837260 | Recruiting

• 1 other identifier: CCR5637
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Although most thyroid cancers are treated and cured successfully there are still 30% who recur after many years. This will eventually progress and at this point may become incurable with treatment options including complex and high risk surgery. The overall efficacy of systemic treatment in advanced thyroid cancer has a good initial response in most patients but not all. The study will collect tissues and blood samples for various protein analysis, nucleic acid extraction and live cell analysis in order to try and detect the presence of plasma ctDNA at baseline of eligible patients.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective of the proposed study is to determine the sensitivity of detecting the presence of plasma ctDNA in patients with advanced and recurrent thyroid cancer

  The primary objective of the proposed study is to determine the sensitivity of detecting the presence of plasma ctDNA in patients with advanced and recurrent thyroid cancer

  5 years

Secondary Outcomes (5)

• Specificity of the absence of plasma ctDNA in patients with advanced and recurrent thyroid cancer at baseline

  5 years

• Association of ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response

  5 years

• Changes in ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response

  5 years

• ctDNA as a biomarker of response to systemic therapy (levels and timing) compared with standard biochemical markers and radiological response in patients starting/during systemic therapy

  5 years

• ctDNA as a biomarker of progression free and overall survival

  5 years

Study Arms (4)

Cohort 1

Patients with newly diagnosed iodine refractory thyroid cancer on surveillance

Other: Sample collection only

Cohort 2

Patients with locally advanced and / or metastatic (Stage 3 \& 4) medullary thyroid cancer

Other: Sample collection only

Cohort 3

Patients with iodine refractory thyroid cancer or advanced/metastatic unresectable MTC due to commence systemic treatment or already on systemic treatment

Other: Sample collection only

Cohort 4

Patients with newly diagnosed anaplastic thyroid cancer

Other: Sample collection only

Interventions

Sample collection only OTHER

Sample collection only

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with thyroid cancer

You may qualify if:

• Age 18 years or older. (all cohorts)
• Patients diagnosed with radioiodine refractory differentiated thyroid carcinoma (RR-DTC) under surveillance. (cohort 1)
• Patients with newly diagnosed resectable locally advanced medullary thyroid cancer Or Patients with newly diagnosed metastatic medullary thyroid cancer for surveillance Or Patients with locally advanced or metastatic medullary thyroid cancer on surveillance (cohort 2)
• Patients with RR-DTC starting systemic therapy Or Patients with RR-DTC on systemic therapy Or Patients with MTC starting systemic therapy Or Patients with MTC on systemic therapy (cohort 3)
• Patients with newly diagnosed anaplastic thyroid cancer (cohort 4)
• Availability of tissue from one archival diagnostic tumour tissue block or be willing to have biopsy of accessible disease (all cohorts)
• Patients must be willing to undergo standard monitoring and treatment as recommended by their clinical team (all cohorts)
• Ability to give informed consent for biological sample collection. (all cohorts)

You may not qualify if:

• Previous or concurrent illness, which in the investigator's opinion would interfere with collection of the complete sample collection
• Any invasive malignancy within previous 5 years (other than non-melanomatous skin carcinoma or carcinoma in situ)
• Pregnancy

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood samples will be collected

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Kate Newbold

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Cheng

CONTACT

02000000000; leslie.cheng@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: March 23, 2023
• Primary Completion (Estimated): February 7, 2027
• Study Completion (Estimated): February 7, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

GB (1)