CancerMARTININCT04853420
Minimal Residual Disease: A Trial Using Liquid Biopsies in Solid Malignancies.
An observational study of Cancer, run by University of Leicester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2021to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Neoplasms, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-24 months
Secondary outcomes (3)
Assess Utility in detecting minimal residual disease
To compare ctDNA mutations and variant frequency in blood samples pre- and post-surgery to assess utility in detection of minimal residual disease
Measured: 12-24 months
Data integration
Ability to integrate data from clinical risk factors, and up-front genotyping.
Measured: 12-24 months
Feasibility of testing platform in clinical setting
Feasibility of returning laboratory analysis in a clinically meaningful timeframe.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start16 Feb 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Thomas, Principal investigator, University of Leicester/University Hospitals Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853420
- Sponsor's protocol ID
- 0792
- Acronym
- MARTINI
- Status last verified
- Mar 2023
- First submitted
- 16 Apr 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease: A Trial Using Liquid Biopsies in Solid Malignancies.
- ClinicalTrials.gov ID
- NCT04853420
- Acronym / sponsor ID
- MARTINI / 0792
- Conditions
- Cancer
- Keywords
- Minimal Residual Disease, liquid biopsy, ctDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-validate the in-house genetic testing platform against the FDA approved Foundation Medicine
Time frame: 12-24 months
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.
3 secondary outcomes
Assess Utility in detecting minimal residual disease
Time frame: 12-24 months
Data integration
Time frame: 12-24 months
Feasibility of testing platform in clinical setting
Time frame: 12-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Thomas principal investigator
University of Leicester/University Hospitals Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-validate the in-house genetic testing platform against the FDA approved Foundation Medicine (time frame: 12-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.