xml: <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/NCT06035471</url>
    </required_header>
    <id_info>
      <org_study_id>Med-Seq Rectal</org_study_id>
      <nct_id>NCT06035471</nct_id>
    </id_info>
    <brief_title>Can we Use a Simple Blood Test to Reduce Unnecessary Adverse Effects From Radiotherapy by Timely Identification of Radiotherapy-resistant Rectal Cancers? MeD-Seq Rectal Study</brief_title>
    <official_title>Can we Use a Simple Blood Test to Reduce Unnecessary Adverse Effects From Radiotherapy by Timely Identification of Radiotherapy-resistant Rectal Cancers? MeD-Seq Rectal Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chemoradiation therapy (CRT) followed by surgery is currently the standard of care to treat&#xD;
        patients with locally advanced rectal cancer (LARC). CRT reduces local recurrences, but is&#xD;
        associated with significant damage to the surrounding healthy tissue that can severely impact&#xD;
        quality of life. Additionally, a proportion of patients (hardly) benefit from CRT. We aim to&#xD;
        develop a diagnostic innovation, which can enable a more selective and thereby more effective&#xD;
        use of the available therapies for rectal cancer patients.&#xD;
  &#xD;
        The objective of this study is to investigate whether patients can be identified who will&#xD;
        response to CRT prior to start of the CRT in rectal cancer and therefore avoid possible&#xD;
        severe side effects in patients who will not reponse on CRT.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>cfDNA methylation markers</measure>
      <time_frame>4 years</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Pathological Response Rate, Circulating Tumour DNA</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MeD-seq</intervention_name>
      <description>MeD-seq analyse: DNA treatment bisulfite --&gt; unmethylated C-nucleotide trabsformed in uracil.--&gt; PCR --&gt; next generation sequencing (NGS) --&gt; localization methylated nucleotides (enzym LpnPI).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Locally advanced rectal cancer patients scheduled for preoperative chemoradiation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Histologically confirmed rectal adenocarcinoma&#xD;
  &#xD;
            -  Scheduled for neoadjuvant chemoradiation&#xD;
  &#xD;
            -  Written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scheduled to another neoadjuvant schedule that comprises systemic chemotherapy or&#xD;
               short-course radiation&#xD;
  &#xD;
            -  Not able to read or understand Dutch language or mentally not capable.&#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_contact>
      <last_name>David Mens, MD</last_name>
      <phone>+31634310799</phone>
      <email>d.mens@erasmusmc.nl</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>C. Verhoef</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035471
  org study id: Med-Seq Rectal
  nct id: NCT06035471
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Chemoradiation therapy (CRT) followed by surgery is currently the standard of care to treat
        patients with locally advanced rectal cancer (LARC). CRT reduces local recurrences, but is
        associated with significant damage to the surrounding healthy tissue that can severely impact
        quality of life. Additionally, a proportion of patients (hardly) benefit from CRT. We aim to
        develop a diagnostic innovation, which can enable a more selective and thereby more effective
        use of the available therapies for rectal cancer patients.
  
        The objective of this study is to investigate whether patients can be identified who will
        response to CRT prior to start of the CRT in rectal cancer and therefore avoid possible
        severe side effects in patients who will not reponse on CRT.
  observational model: Cohort
  time perspective: Prospective
  measure: cfDNA methylation markers
  time frame: 4 years
  intervention type: Diagnostic Test
  intervention name: MeD-seq
  description: MeD-seq analyse: DNA treatment bisulfite --> unmethylated C-nucleotide trabsformed in uracil.--> PCR --> next generation sequencing (NGS) --> localization methylated nucleotides (enzym LpnPI).
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Mens, MD
  phone: +31634310799
  email: d.mens@erasmusmc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: C. Verhoef
  investigator title: Professor
  mesh term: Rectal Neoplasms
  sharing ipd: Undecided