<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/NCT04438681</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01423-36</org_study_id>
    <nct_id>NCT04438681</nct_id>
  </id_info>
  <brief_title>Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients</brief_title>
  <acronym>INSTIGO</acronym>
  <official_title>INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Jean Perrin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Jean Perrin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The INSTIGO study aims to assess a plasma protein profile at different stages of patient&#xD;
      follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer.&#xD;
      It also aims to look at other potential biomarkers of metastatic relapse such as&#xD;
      Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a&#xD;
      tumor RNA signature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to carry out a study that measures the concentrations of a set of&#xD;
      plasma proteins in order to assess their ability to predict metastatic relapse of triple&#xD;
      negative breast cancer. A plasma protein profile could be an interesting biomarker since it&#xD;
      is easily accessible and quantifiable.&#xD;
&#xD;
      The investigators also propose to search relation between metastatic relapse in TNBC and&#xD;
      other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs),&#xD;
      figurative blood components and circulating tumour DNA (ctDNA).&#xD;
&#xD;
      Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center,&#xD;
      by analyzing the RNA expression of 8 genes.&#xD;
&#xD;
      Before treatment begins, the patient will take an initial blood sample. A second blood sample&#xD;
      will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A&#xD;
      third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a&#xD;
      5th blood sample will be done at 6 months and 1 year respectively after the end of the&#xD;
      radiotherapy. A part of these blood samples will be used for the quantification of&#xD;
      circulating proteins, for the determination of the blood's figurative elements and for the&#xD;
      quantification of circulating tumour DNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2020</start_date>
  <completion_date type="Anticipated">November 9, 2029</completion_date>
  <primary_completion_date type="Anticipated">November 9, 2023</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>Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)</measure>
    <time_frame>8 years</time_frame>
    <description>- Plasma concentrations of a set of proteins at diagnosis (measured in g/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)</measure>
    <time_frame>8 years</time_frame>
    <description>- Time to metastatic relapse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy</measure>
    <time_frame>8 years</time_frame>
    <description>- Plasma concentrations of a set of proteins (measured in g/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy</measure>
    <time_frame>8 years</time_frame>
    <description>- Time to metastatic relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of a characteristic plasma protein profile at the time of metastatic relapse</measure>
    <time_frame>8 years</time_frame>
    <description>- Plasma concentrations of a set of proteins (measured in g/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.</measure>
    <time_frame>8 years</time_frame>
    <description>- Tumor lymphocyte infiltration rate before treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse</measure>
    <time_frame>8 years</time_frame>
    <description>- Measurement of plasma ctDNA level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse</measure>
    <time_frame>8 years</time_frame>
    <description>- Time to metastatic relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse</measure>
    <time_frame>8 years</time_frame>
    <description>- The values of NLR and PLR at diagnosis (no Unit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors</measure>
    <time_frame>8 years</time_frame>
    <description>- RNA expression of 6 genes of interest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy</measure>
    <time_frame>3 years and 6 months</time_frame>
    <description>- Plasma concentrations of a set of proteins at diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy</measure>
    <time_frame>3 years and 6 months</time_frame>
    <description>- Histological response according to the Sataloff classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .</measure>
    <time_frame>3 years and 6 months</time_frame>
    <description>- Tumor lymphocyte infiltration rate before treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy</measure>
    <time_frame>3 years and 6 months</time_frame>
    <description>The values of NLR and PLR at diagnosis&#xD;
The values of NLR and PLR after neoadjuvant chemotherapy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women diagnosed with primitive, non-metastatic, histologically proved, triple negative&#xD;
        breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Diagnosed with primitive, non-metastatic, histologically proved, triple negative&#xD;
             breast cancer&#xD;
&#xD;
          -  Patient able to understand the French language&#xD;
&#xD;
          -  Patient affiliated to social security&#xD;
&#xD;
          -  Obtaining signed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons deprived of their freedom or under guardianship or incapable of giving consent&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hugo VEYSSIERE</last_name>
    <phone>0473278005</phone>
    <email>hugo.veyssiere@clermont.unicancer.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Jean PERRIN</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hugo VEYSSIERE</last_name>
      <phone>0473278005</phone>
      <email>hugo.veyssiere@clermont.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Xavier DURANDO, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04438681
org study id: 2020-A01423-36
nct id: NCT04438681
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The INSTIGO study aims to assess a plasma protein profile at different stages of patient
      follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer.
      It also aims to look at other potential biomarkers of metastatic relapse such as
      Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a
      tumor RNA signature.
The investigators propose to carry out a study that measures the concentrations of a set of
      plasma proteins in order to assess their ability to predict metastatic relapse of triple
      negative breast cancer. A plasma protein profile could be an interesting biomarker since it
      is easily accessible and quantifiable.

      The investigators also propose to search relation between metastatic relapse in TNBC and
      other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs),
      figurative blood components and circulating tumour DNA (ctDNA).

      Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center,
      by analyzing the RNA expression of 8 genes.

      Before treatment begins, the patient will take an initial blood sample. A second blood sample
      will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A
      third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a
      5th blood sample will be done at 6 months and 1 year respectively after the end of the
      radiotherapy. A part of these blood samples will be used for the quantification of
      circulating proteins, for the determination of the blood's figurative elements and for the
      quantification of circulating tumour DNA.
observational model: Cohort
time perspective: Prospective
measure: Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
time frame: 8 years
description: - Plasma concentrations of a set of proteins at diagnosis (measured in g/L)
measure: Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
time frame: 8 years
description: - Time to metastatic relapse
measure: Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
time frame: 8 years
description: - Plasma concentrations of a set of proteins (measured in g/L)
measure: Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
time frame: 8 years
description: - Time to metastatic relapse
measure: Identification of a characteristic plasma protein profile at the time of metastatic relapse
time frame: 8 years
description: - Plasma concentrations of a set of proteins (measured in g/L)
measure: Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.
time frame: 8 years
description: - Tumor lymphocyte infiltration rate before treatment
measure: Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
time frame: 8 years
description: - Measurement of plasma ctDNA level
measure: Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
time frame: 8 years
description: - Time to metastatic relapse
measure: Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse
time frame: 8 years
description: - The values of NLR and PLR at diagnosis (no Unit)
measure: Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors
time frame: 8 years
description: - RNA expression of 6 genes of interest
measure: Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
time frame: 3 years and 6 months
description: - Plasma concentrations of a set of proteins at diagnosis
measure: Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
time frame: 3 years and 6 months
description: - Histological response according to the Sataloff classification
measure: Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .
time frame: 3 years and 6 months
description: - Tumor lymphocyte infiltration rate before treatment
measure: Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy
time frame: 3 years and 6 months
description: The values of NLR and PLR at diagnosis
The values of NLR and PLR after neoadjuvant chemotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hugo VEYSSIERE
phone: 0473278005
email: hugo.veyssiere@clermont.unicancer.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms