Minimal Residual Disease: A Trial Using Liquid Biopsies in Solid Malignancies.

NCT04853420 | Active Not Recruiting

• 1 other identifier: 0792
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The NHS' Genomic Medicine Service offers whole genome sequencing as part of the drive to improve cancer outcomes. It is recognised that actionable mutations (current and emerging), will ultimately improve outcomes across multiple disease sites by identifying which treatments may benefit individual patients the most, and by providing earlier and more accurate diagnoses. However, testing in the cancer setting is currently limited to haematological malignancies and sarcoma. The majority of patients with solid tumours do not yet have access to this platform and the benefits that it may bring. Therefore, expanding genomic testing capacity within a research setting has potential to benefit those patients that would otherwise not be able to access testing. In this study we will be using tissue derived from patients undergoing surgery for cancer to validate an in-house genomic testing platform against Roche's Foundation Medicine genomic profile service, which is an FDA- approved commercial platform. In addition, two blood samples will be taken in order that we can test whether markers present in the tissue may also be seen in blood. We hope that this will help us monitor minimal residual disease in patients, allowing earlier detection of relapse/recurrence than radiology currently allows. Patients may also agree to donate optional excess fresh tissue from their surgery. This will be integrated with other laboratory platforms which may offer information on prospective drug response based on genotypic profiles (e.g., patient-derived explants).

Conditions

Cancer

Keywords

Minimal Residual Disease; liquid biopsy; ctDNA

Outcome Measures

Primary Outcomes (1)

• Cross-validate the in-house genetic testing platform against the FDA approved Foundation Medicine

  To cross-validate the Thermofisher Oncomine tissue and cfTNA assays (in house) against the FDA approved Foundation Medicine platform by comparison of the spectrum and variant frequency of cancer-specific alterations detected in matched tissue and blood.

  12-24 months

Secondary Outcomes (3)

• Assess Utility in detecting minimal residual disease

  12-24 months

• Data integration

  12-24 months

• Feasibility of testing platform in clinical setting

  12-24 months

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

Trial participants will consist of patients with solid tumours that have a high likelihood of rapid post-surgical relapse. Such tumours types typically include gastroesophageal, gastrointestinal cancers and colorectal liver metastases, but other malignancies will also be considered.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with solid tumour that requires surgical resection, and has a high propensity of relapse.
• Fit for planned surgical procedure.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Willing to allow his or her General Practitioner, Consultant, and Clinical Geneticist, if appropriate, to be notified of participation in the study.

You may not qualify if:

• Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
• Not fit for surgery.
• Not willing to donate blood and tissue samples.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Participants who have participated in another research study involving an investigational product in the past 12 weeks.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hospitals of Leicester

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Thomas

  University of Leicester/University Hospitals Leicester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: February 16, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 10, 2023

Record last verified: 2023-03

Locations

GB (1)