CancerCALIBRATENCT02994511
Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials
An observational study of Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial summary
This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive factor of response/resistance to anticancer treatment. The project will involve the collection and study of the archived tumour tissue where available (mandatory), serial blood samples (mandatory) and fresh tumour biopsies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2014to 30 Mar 2020
- 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: All the patients potentially eligible for early phase experimental therapeutic trials will be invited to take part in this study.
Who may be able to join
- Histological or cytological confirmation of cancer
- Patient being considered for participation in an experimental therapeutic trials
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule (such conditions should be discussed with the patient before registration in the study)
Who cannot join
- Age below 18 years old
- Patient not physically and mentally able to give informed consent.
Trial locations and contacts
1 site in 1 country.
Lisa Bax contact
Richard Baird contact
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Lisa Bax, lisa.bax@addenbrookes.nhs.uk
Richard Baird
About this study
This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive factor of response/resistance to anticancer treatment. The project will involve the collection and study of the archived tumour tissue where available (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an early phase clinical trial.
Read the detailed description
Some patients respond to anti-cancer drugs whilst others do not, despite having tumours with, apparently, similar characteristics such as site of origin. This variability in response can in some cases be explained by the genetic profile of the tumour. Therefore, studying the relationship between the molecular profiles of individual cancers and the response to therapy over time is of crucial importance in drug development. However, this endeavour is hampered by the difficulty in accessing suitable tumour material for analysis. Many patients' tumours are at anatomical sites which make biopsy difficult / hazardous which is in addition to the discomfort of a biopsy procedure. Therefore, this study will explore the potential of the circulating tumour DNA as a predictive factor of response/resistance to anticancer treatment.
For patients recruited to early phase clinical trials of experimental therapies, archival tumour tissue (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) will be collected according to the individual schedule of each clinical trial.
Blood plasma samples will be tested for cell-free and ctDNA levels and genomic profiles, which may include analyses of mutational profiles, copy number variations, translocations, chromosomal rearrangements and/or epigenetic profiles.
Molecular profiling of archival and fresh tumour biopsies will also be carried out to study the correlation with cell-free and ctDNA samples and investigate the potential predictor response/resistance to treatment.
- Conditions
- Cancer
- Keywords
- Circulating tumour DNA, ctDNA
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the change in circulating tumor DNA [ctDNA] levels of patients on experimental therapeutic trials.
ctDNA levels will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
Measured: From baseline to the end of study, defined as 'disease progression or evidence of unacceptable toxicity', whichever comes first, measured at the start of each cycle (cycle = approximately 3 weeks) and CT scan (every 2 cycles), for up to 100 months.
Secondary outcomes (3)
Acceptability of research sampling
Acceptability of research tumour biopsies will be assessed by providing a patient with an 'Acceptability Questionnaire' pre and post biopsy.
Measured: Optional fresh tissue biopsies are planned to be taken at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Safety of tumour biopsies for patients with cancer on experimental therapeutic trials
Serious Adverse events at least possibly related to the research biopsy procedure will be collected prospectively. In addition, information related to the medical history and biopsy procedure will be recorded at the different time points.
Measured: Assessed at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Gene Mutation profiles in ctDNA and tumour biopsies (where available) over time for patients with cancer on experimental therapeutic trials
Gene mutation profiles will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
Measured: From baseline, at the time points specified in Outcomes 1 and 2, until the end of study, defined as 'disease progression or evidence of unacceptable toxicity', for up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start8 Dec 2014
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Mar 2020 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Richard Baird, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994511
- Sponsor's protocol ID
- CALIBRATE
- Acronym
- CALIBRATE
- Status last verified
- Jul 2019
- First submitted
- 17 Mar 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials
- ClinicalTrials.gov ID
- NCT02994511
- Acronym / sponsor ID
- CALIBRATE / CALIBRATE
- Conditions
- Cancer
- Keywords
- Circulating tumour DNA, ctDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- 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.
This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive factor of response/resistance to anticancer treatment. The project will involve the collection and study of the archived tumour tissue where available (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an early phase clinical trial.
Detailed description
Some patients respond to anti-cancer drugs whilst others do not, despite having tumours with, apparently, similar characteristics such as site of origin. This variability in response can in some cases be explained by the genetic profile of the tumour. Therefore, studying the relationship between the molecular profiles of individual cancers and the response to therapy over time is of crucial importance in drug development. However, this endeavour is hampered by the difficulty in accessing suitable tumour material for analysis. Many patients' tumours are at anatomical sites which make biopsy difficult / hazardous which is in addition to the discomfort of a biopsy procedure. Therefore, this study will explore the potential of the circulating tumour DNA as a predictive factor of response/resistance to anticancer treatment.
For patients recruited to early phase clinical trials of experimental therapies, archival tumour tissue (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) will be collected according to the individual schedule of each clinical trial.
Blood plasma samples will be tested for cell-free and ctDNA levels and genomic profiles, which may include analyses of mutational profiles, copy number variations, translocations, chromosomal rearrangements and/or epigenetic profiles.
Molecular profiling of archival and fresh tumour biopsies will also be carried out to study the correlation with cell-free and ctDNA samples and investigate the potential predictor response/resistance to treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients potentially eligible for early phase experimental therapeutic trials will be invited to take part in this study.
Key inclusion criteria (3 listed)
- Histological or cytological confirmation of cancer
- Patient being considered for participation in an experimental therapeutic trials
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule (such conditions should be discussed with the patient before registration in the study)
Key exclusion criteria (2 listed)
- Age below 18 years old
- Patient not physically and mentally able to give informed consent.
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
Assessment of the change in circulating tumor DNA [ctDNA] levels of patients on experimental therapeutic trials.
Time frame: From baseline to the end of study, defined as 'disease progression or evidence of unacceptable toxicity', whichever comes first, measured at the start of each cycle (cycle = approximately 3 weeks) and CT scan (every 2 cycles), for up to 100 months.
ctDNA levels will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
3 secondary outcomes
Acceptability of research sampling
Time frame: Optional fresh tissue biopsies are planned to be taken at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Safety of tumour biopsies for patients with cancer on experimental therapeutic trials
Time frame: Assessed at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months.
Gene Mutation profiles in ctDNA and tumour biopsies (where available) over time for patients with cancer on experimental therapeutic trials
Time frame: From baseline, at the time points specified in Outcomes 1 and 2, until the end of study, defined as 'disease progression or evidence of unacceptable toxicity', for up to 100 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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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.
Lisa Bax contact
Richard Baird contact
Richard Baird principal investigator
Cambridge University Hospitals NHS Foundation Trust
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 CCTU- Cancer Theme 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 3 inclusion and 2 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 22 Jul 2019. 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?
Contact Lisa Bax (lisa.bax@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the change in circulating tumor DNA [ctDNA] levels of patients on experimental therapeutic trials. (time frame: From baseline to the end of study, defined as 'disease progression or evidence of unacceptable toxicity', whichever comes first, measured at the start of each cycle (cycle = approximately 3 weeks) and CT scan (every 2 cycles), for up to 100 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 22 Jul 2019.