<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03256084</url>
  </required_header>
  <id_info>
    <org_study_id>CTC-Côlon-IPC 2015-020</org_study_id>
    <nct_id>NCT03256084</nct_id>
  </id_info>
  <brief_title>Tumoral Circulating Cells and Colorectal Cancer Progression</brief_title>
  <official_title>Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beckman Coulter, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Paoli-Calmettes</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>
      Prospective research of circulating tumor cells as markers of progression risk in colorectal&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims at allowing a better understanding of which circulating tumor cells (CTC)&#xD;
      have the higher risk of metastasis of in the overall population of CTC.&#xD;
&#xD;
      Prospective monocenter open-label study.&#xD;
&#xD;
      In the frame of the management of the disease, blood samples will be collected at different&#xD;
      times of treatment, regarding disease status (localized of stage II/III, metastatic non&#xD;
      resectable, metastatic potentially resectable). Tissue samples will be collected for patients&#xD;
      scheduled for surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of CTC features</measure>
    <time_frame>Group 1: at surgery, 4 (+/- 1) weeks post-surgery, at progression. Group 2: before chemotherapy, after 4 months treatment (responders), at progression. Group 3: before neoadjuvant surgery, at surgery, 4 (+/- 1) weeks post-surgery, at progression.</time_frame>
    <description>Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Colorectal Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Localized stage II/III (group 1), metastatic non resectable (group 2), metastatic potentially resectable (group 3).&#xD;
Additional blood samples specific for the research will be collected. Tissue samples will be taken on surgical specimens from surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood and tumor samples</intervention_name>
    <description>Blood and tumor samples</description>
    <arm_group_label>Colorectal Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient of more than 18 years old&#xD;
&#xD;
          2. Histological diagnosis of colic adenocarcinoma metastatic or not&#xD;
&#xD;
          3. Before any treatment with systemic chemotherapy&#xD;
&#xD;
          4. Patient affiliated to, or beneficiating of the national security&#xD;
&#xD;
          5. Patient having signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with previous chemothrapy treatment&#xD;
&#xD;
          2. Patient with more than one evolutive tumoral pathology&#xD;
&#xD;
          3. Patient under long-term immunosuppressor treatment&#xD;
&#xD;
          4. Patient with severe infection&#xD;
&#xD;
          5. Pregnant or breasting woman&#xD;
&#xD;
          6. Person in an emergency situation, adult subject to a legal protection measure (a&#xD;
             guardian, guardianship or safeguard of justice), or unable of expressing his / her&#xD;
             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>Jean-Luc RAOUL, Pr</last_name>
    <role>Study Director</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique GENRE, MD</last_name>
    <phone>+33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabelle BOQUET, PhD</last_name>
    <phone>+33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Luc RAOUL, MD</last_name>
      <phone>33491223778</phone>
      <email>drci.up@ipc.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Luc RAOUL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://institutpaolicalmettes.fr</url>
    <description>Official Website of the Sponsor</description>
  </link>
  <results_reference>
    <citation>Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Vieitez JM, Alonso V, Gravalos C, Escudero P, Vera R, Aranda E, Garcia-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, Lopez-Ladron A, Diaz-Rubio E. Role of circulating tumor cells as prognostic marker in resected stage III colorectal cancer. Ann Oncol. 2015 Mar;26(3):535-41. doi: 10.1093/annonc/mdu568. Epub 2014 Dec 15.</citation>
    <PMID>25515656</PMID>
  </results_reference>
  <results_reference>
    <citation>Hodgkinson CL, Morrow CJ, Li Y, Metcalf RL, Rothwell DG, Trapani F, Polanski R, Burt DJ, Simpson KL, Morris K, Pepper SD, Nonaka D, Greystoke A, Kelly P, Bola B, Krebs MG, Antonello J, Ayub M, Faulkner S, Priest L, Carter L, Tate C, Miller CJ, Blackhall F, Brady G, Dive C. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer. Nat Med. 2014 Aug;20(8):897-903. doi: 10.1038/nm.3600. Epub 2014 Jun 1.</citation>
    <PMID>24880617</PMID>
  </results_reference>
  <results_reference>
    <citation>Yu M, Bardia A, Aceto N, Bersani F, Madden MW, Donaldson MC, Desai R, Zhu H, Comaills V, Zheng Z, Wittner BS, Stojanov P, Brachtel E, Sgroi D, Kapur R, Shioda T, Ting DT, Ramaswamy S, Getz G, Iafrate AJ, Benes C, Toner M, Maheswaran S, Haber DA. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014 Jul 11;345(6193):216-20. doi: 10.1126/science.1253533.</citation>
    <PMID>25013076</PMID>
  </results_reference>
  <results_reference>
    <citation>Khoo BL, Lee SC, Kumar P, Tan TZ, Warkiani ME, Ow SG, Nandi S, Lim CT, Thiery JP. Short-term expansion of breast circulating cancer cells predicts response to anti-cancer therapy. Oncotarget. 2015 Jun 20;6(17):15578-93. doi: 10.18632/oncotarget.3903.</citation>
    <PMID>26008969</PMID>
  </results_reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03256084
org study id: CTC-Côlon-IPC 2015-020
nct id: NCT03256084
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective research of circulating tumor cells as markers of progression risk in colorectal
      cancer.
This study aims at allowing a better understanding of which circulating tumor cells (CTC)
      have the higher risk of metastasis of in the overall population of CTC.

      Prospective monocenter open-label study.

      In the frame of the management of the disease, blood samples will be collected at different
      times of treatment, regarding disease status (localized of stage II/III, metastatic non
      resectable, metastatic potentially resectable). Tissue samples will be collected for patients
      scheduled for surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Evaluation of CTC features
time frame: Group 1: at surgery, 4 (+/- 1) weeks post-surgery, at progression. Group 2: before chemotherapy, after 4 months treatment (responders), at progression. Group 3: before neoadjuvant surgery, at surgery, 4 (+/- 1) weeks post-surgery, at progression.
description: Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.
arm group label: Colorectal Cancer
arm group type: Experimental
description: Localized stage II/III (group 1), metastatic non resectable (group 2), metastatic potentially resectable (group 3).
Additional blood samples specific for the research will be collected. Tissue samples will be taken on surgical specimens from surgery.
intervention type: Procedure
intervention name: Blood and tumor samples
description: Blood and tumor samples
arm group label: Colorectal Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Luc RAOUL, Pr
role: Study Director
affiliation: Institut Paoli-Calmettes
last name: Dominique GENRE, MD
phone: +33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
last name: Isabelle BOQUET, PhD
phone: +33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
url: http://institutpaolicalmettes.fr
description: Official Website of the Sponsor
citation: Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Vieitez JM, Alonso V, Gravalos C, Escudero P, Vera R, Aranda E, Garcia-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, Lopez-Ladron A, Diaz-Rubio E. Role of circulating tumor cells as prognostic marker in resected stage III colorectal cancer. Ann Oncol. 2015 Mar;26(3):535-41. doi: 10.1093/annonc/mdu568. Epub 2014 Dec 15.
PMID: 25515656
citation: Hodgkinson CL, Morrow CJ, Li Y, Metcalf RL, Rothwell DG, Trapani F, Polanski R, Burt DJ, Simpson KL, Morris K, Pepper SD, Nonaka D, Greystoke A, Kelly P, Bola B, Krebs MG, Antonello J, Ayub M, Faulkner S, Priest L, Carter L, Tate C, Miller CJ, Blackhall F, Brady G, Dive C. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer. Nat Med. 2014 Aug;20(8):897-903. doi: 10.1038/nm.3600. Epub 2014 Jun 1.
PMID: 24880617
citation: Yu M, Bardia A, Aceto N, Bersani F, Madden MW, Donaldson MC, Desai R, Zhu H, Comaills V, Zheng Z, Wittner BS, Stojanov P, Brachtel E, Sgroi D, Kapur R, Shioda T, Ting DT, Ramaswamy S, Getz G, Iafrate AJ, Benes C, Toner M, Maheswaran S, Haber DA. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014 Jul 11;345(6193):216-20. doi: 10.1126/science.1253533.
PMID: 25013076
citation: Khoo BL, Lee SC, Kumar P, Tan TZ, Warkiani ME, Ow SG, Nandi S, Lim CT, Thiery JP. Short-term expansion of breast circulating cancer cells predicts response to anti-cancer therapy. Oncotarget. 2015 Jun 20;6(17):15578-93. doi: 10.18632/oncotarget.3903.
PMID: 26008969
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No