<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02994511</url>
  </required_header>
  <id_info>
    <org_study_id>CALIBRATE</org_study_id>
    <nct_id>NCT02994511</nct_id>
  </id_info>
  <brief_title>Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials</brief_title>
  <acronym>CALIBRATE</acronym>
  <official_title>Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CCTU- Cancer Theme</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive&#xD;
      factor of response/resistance to anticancer treatment. The project will involve the&#xD;
      collection and study of the archived tumour tissue where available (mandatory), serial blood&#xD;
      samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an&#xD;
      early phase clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some patients respond to anti-cancer drugs whilst others do not, despite having tumours with,&#xD;
      apparently, similar characteristics such as site of origin. This variability in response can&#xD;
      in some cases be explained by the genetic profile of the tumour. Therefore, studying the&#xD;
      relationship between the molecular profiles of individual cancers and the response to therapy&#xD;
      over time is of crucial importance in drug development. However, this endeavour is hampered&#xD;
      by the difficulty in accessing suitable tumour material for analysis. Many patients' tumours&#xD;
      are at anatomical sites which make biopsy difficult / hazardous which is in addition to the&#xD;
      discomfort of a biopsy procedure. Therefore, this study will explore the potential of the&#xD;
      circulating tumour DNA as a predictive factor of response/resistance to anticancer treatment.&#xD;
&#xD;
      For patients recruited to early phase clinical trials of experimental therapies, archival&#xD;
      tumour tissue (mandatory), serial blood samples (mandatory) and fresh tumour biopsies&#xD;
      (optional) will be collected according to the individual schedule of each clinical trial.&#xD;
&#xD;
      Blood plasma samples will be tested for cell-free and ctDNA levels and genomic profiles,&#xD;
      which may include analyses of mutational profiles, copy number variations, translocations,&#xD;
      chromosomal rearrangements and/or epigenetic profiles.&#xD;
&#xD;
      Molecular profiling of archival and fresh tumour biopsies will also be carried out to study&#xD;
      the correlation with cell-free and ctDNA samples and investigate the potential predictor&#xD;
      response/resistance to treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 8, 2014</start_date>
  <completion_date type="Anticipated">March 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the change in circulating tumor DNA [ctDNA] levels of patients on experimental therapeutic trials.</measure>
    <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.</time_frame>
    <description>ctDNA levels will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of research sampling</measure>
    <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.</time_frame>
    <description>Acceptability of research tumour biopsies will be assessed by providing a patient with an 'Acceptability Questionnaire' pre and post biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of tumour biopsies for patients with cancer on experimental therapeutic trials</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene Mutation profiles in ctDNA and tumour biopsies (where available) over time for patients with cancer on experimental therapeutic trials</measure>
    <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.</time_frame>
    <description>Gene mutation profiles will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumour samples Blood Samples ctDNA isolated from bloods samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients potentially eligible for early phase experimental therapeutic trials will&#xD;
        be invited to take part in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Histological or cytological confirmation of cancer&#xD;
&#xD;
          -  Patient being considered for participation in an experimental therapeutic trials&#xD;
&#xD;
          -  Absence of any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow up schedule (such&#xD;
             conditions should be discussed with the patient before registration in the study)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age below 18 years old&#xD;
&#xD;
          -  Patient not physically and mentally able to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Baird</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Bax</last_name>
    <email>lisa.bax@addenbrookes.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Richard Baird</last_name>
    <email>rdb39@medschl.cam.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Bax</last_name>
      <email>lisa.bax@addenbrookes.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Richard Baird</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simon Pacey</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>March 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>July 19, 2019</last_update_submitted>
  <last_update_submitted_qc>July 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>CCTU- Cancer Theme</investigator_full_name>
    <investigator_title>Dr Richard Baird</investigator_title>
  </responsible_party>
  <keyword>Circulating tumour DNA</keyword>
  <keyword>ctDNA</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02994511
org study id: CALIBRATE
nct id: NCT02994511
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Other
time perspective: Prospective
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.
description: ctDNA levels will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
measure: 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.
description: Acceptability of research tumour biopsies will be assessed by providing a patient with an 'Acceptability Questionnaire' pre and post biopsy.
measure: 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.
description: 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.
measure: 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.
description: Gene mutation profiles will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer.
Tumour samples Blood Samples ctDNA isolated from bloods samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Baird
role: Principal Investigator
affiliation: Cambridge University Hospitals NHS Foundation Trust
last name: Lisa Bax
email: lisa.bax@addenbrookes.nhs.uk
last name: Richard Baird
email: rdb39@medschl.cam.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: CCTU- Cancer Theme
investigator title: Dr Richard Baird