Investigating Utility of ctDNA and Tumour Evolution in Advanced Thyroid Cancer

NCT ID: NCT05837260

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2027-02-07

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.

Detailed Description

The treatment decisions are based on relying on radiological parameters such as using the RECIST criteria and measuring the rise in certain serum tumour biomarkers. However, the disadvantage of this is that this method can take many months to detect a change in disease volume. An improved understanding of genetics and cancer and potential gene sequencing can help achieve personalised treatment for patients. However, there are many questions and issues that still need to be answered and require urgent attention before being able to achieve optimate patient stratification. We need to identify better tumour biomarkers to detect disease progression, show real time response to treatment and understand why tumours evolve to becoming more aggressive. This study hopes to address these issues by proposing a multicentre prospective study to investigate the presence and role of ctDNA in advanced thyroid cancer including differentiated thyroid cancer , medullary thyroid cancer and Anaplastic Thyroid Cancer.

Conditions

Thyroid Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

Patients with newly diagnosed iodine refractory thyroid cancer on surveillance

Sample collection only

Intervention Type: OTHER

Sample collection only

Cohort 2

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

Sample collection only

Intervention Type: 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

Sample collection only

Intervention Type: OTHER

Sample collection only

Cohort 4

Patients with newly diagnosed anaplastic thyroid cancer

Sample collection only

Intervention Type: OTHER

Sample collection only

Interventions

Sample collection only

Sample collection only

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kate Newbold

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Leslie Cheng

Role: CONTACT

leslie.cheng@rmh.nhs.uk

02000000000

Facility Contacts

Leslie Cheng

Role: primary

leslie.cheng@rmh.nhs.uk

Other Identifiers

CCR5637

Identifier Type: -

Identifier Source: org_study_id