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/NCT06007794</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0368</org_study_id>
      <nct_id>NCT06007794</nct_id>
    </id_info>
    <brief_title>Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)</brief_title>
    <acronym>JUMPresearchII</acronym>
    <official_title>Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a&#xD;
        significant number of them either in a context of recovery or in prolonged remission close to&#xD;
        a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises&#xD;
        many challenges for the patient, his entourage, the medical profession and our society. One&#xD;
        of the major challenges is the detection and management of treatment side effects for all&#xD;
        patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test,&#xD;
        blood count), we are mainly interested in muscle deconditioning and cognitive impairment,&#xD;
        which are particularly disturbed in these populations. After the evaluation day, patients are&#xD;
        referred to the most appropriate structures (Adapted physical activity, sports for health,&#xD;
        and rehabilitation at Henry Gabriel Hospital).&#xD;
  &#xD;
        JUMP research is part of axis 2 of the 2021-2030 cancer plan: &quot;Limiting sequelae and&#xD;
        improving quality of life&quot;, through sheets 1 (research) / 6 (access and quality) / 7&#xD;
        (prevention). This leads to the concrete implementation on the territory of adapted care&#xD;
        channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA)&#xD;
        structures, associative structures; which makes it possible to develop and strengthen the&#xD;
        city-hospital link. Finally, it allows the patient to take ownership and get involved in the&#xD;
        project, allowing in the future to make them truly active in they care and to advise and&#xD;
        motivate their peers.&#xD;
  &#xD;
        This non-interventional research is classified as &quot;research involving human subjects&quot;, class&#xD;
        3 .&#xD;
  &#xD;
        The objective of this research is to evaluate the impact of cancer on the musculoskeletal&#xD;
        system and to test ultrasound as a clinical examination for the detection of sarcopenia in&#xD;
        this population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2032</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2032</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA Mean thickness of the quadriceps (straight femoris) measured by ultrasound compared to the Appendicular Lean Mass/size² in DEXA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Description of muscle evaluation parameters in the JUMP population compared to the references described</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>Number of patients with below-average results in reference physical activity tests performed during JUMP dayreferences described : adjustment for age and sex</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of the number of sarcopenic patients in the JUMP population ccording to the definitions of EWGSOP2</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of EWGSOP2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of BAUMGARTNER</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of BAUMGARTNER</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rate of correlation between fatigue and muscle indices in the JUMP population.</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>Association between fatigue and muscle indices in the JUMP population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rate of correlation between the ultrasound muscle index and the scannographic muscle index of the paravertebrals</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>Correlation between the ultrasound muscle index and the scannographic muscle index of the paravertebrals (SMI L3, T12 and T7)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of correlation between muscle biological markers and the diagnosis of sarcopenia</measure>
      <time_frame>through study completion, an average of 9 years</time_frame>
      <description>muscle biological markers are tyrosine, myostatin, FGF19, decarboxylated osteocalcin</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Cancer</condition>
    <condition>Post-cancer</condition>
    <condition>Hematology</condition>
    <arm_group>
      <arm_group_label>JUMP group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study concerns adults with cancer treated with chemotherapy, radiotherapy, hormonal therapy or immunotherapy, in remission or cured. Patients took part in the dedicated post-cancer assessment day. In addition, an ultrasound of the thigh is performed to measure the size of the quadriceps on 5 different measurements.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>JUMP group</intervention_name>
      <description>patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment</description>
      <arm_group_label>JUMP group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age : 18 to 74 years&#xD;
  &#xD;
            -  localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney,&#xD;
               ovary, colon and pancreas, hemopathy&#xD;
  &#xD;
            -  patient who benefited from the post-cancer assessment day&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active cancer (relapse or new cancer)&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Major cognitive impairment making comprehension and exercise difficult&#xD;
  &#xD;
            -  Amputation of both lower limbs (for ultrasound)&#xD;
  &#xD;
            -  Difficulty understanding oral and written French&#xD;
  &#xD;
            -  Adults under legal protection (guardianship, curatorship or safeguard of justice)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cyrille CONFAVREUX, Md,PhD</last_name>
      <phone>+33 4 78 86 12 31</phone>
      <email>Cyrille.confavreux@chu-lyon.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital Lyon Sud, rhumatologie</name>
        <address>
          <city>Pierre-Bénite</city>
          <zip>69495</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Cyrille CONFAVREUX, Md,PhD</last_name>
        <phone>+334 78 86 12 31</phone>
        <email>Cyrille.confavreux@chu-lyon.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>post-cancer</keyword>
    <keyword>sarcopenia</keyword>
    <keyword>medical evaluation</keyword>
    <keyword>muscle</keyword>
    <!-- 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/NCT06007794
  org study id: 69HCL23_0368
  nct id: NCT06007794
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a
        significant number of them either in a context of recovery or in prolonged remission close to
        a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises
        many challenges for the patient, his entourage, the medical profession and our society. One
        of the major challenges is the detection and management of treatment side effects for all
        patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test,
        blood count), we are mainly interested in muscle deconditioning and cognitive impairment,
        which are particularly disturbed in these populations. After the evaluation day, patients are
        referred to the most appropriate structures (Adapted physical activity, sports for health,
        and rehabilitation at Henry Gabriel Hospital).
  
        JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and
        improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7
        (prevention). This leads to the concrete implementation on the territory of adapted care
        channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA)
        structures, associative structures; which makes it possible to develop and strengthen the
        city-hospital link. Finally, it allows the patient to take ownership and get involved in the
        project, allowing in the future to make them truly active in they care and to advise and
        motivate their peers.
  
        This non-interventional research is classified as "research involving human subjects", class
        3 .
  
        The objective of this research is to evaluate the impact of cancer on the musculoskeletal
        system and to test ultrasound as a clinical examination for the detection of sarcopenia in
        this population.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA
  time frame: through study completion, an average of 9 years
  description: Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA Mean thickness of the quadriceps (straight femoris) measured by ultrasound compared to the Appendicular Lean Mass/size² in DEXA
  measure: Description of muscle evaluation parameters in the JUMP population compared to the references described
  time frame: through study completion, an average of 9 years
  description: Number of patients with below-average results in reference physical activity tests performed during JUMP dayreferences described : adjustment for age and sex
  measure: Quantification of the number of sarcopenic patients in the JUMP population ccording to the definitions of EWGSOP2
  time frame: through study completion, an average of 9 years
  description: Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of EWGSOP2
  measure: Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of BAUMGARTNER
  time frame: through study completion, an average of 9 years
  description: Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of BAUMGARTNER
  measure: rate of correlation between fatigue and muscle indices in the JUMP population.
  time frame: through study completion, an average of 9 years
  description: Association between fatigue and muscle indices in the JUMP population.
  measure: rate of correlation between the ultrasound muscle index and the scannographic muscle index of the paravertebrals
  time frame: through study completion, an average of 9 years
  description: Correlation between the ultrasound muscle index and the scannographic muscle index of the paravertebrals (SMI L3, T12 and T7)
  measure: Rate of correlation between muscle biological markers and the diagnosis of sarcopenia
  time frame: through study completion, an average of 9 years
  description: muscle biological markers are tyrosine, myostatin, FGF19, decarboxylated osteocalcin
  arm group label: JUMP group
  arm group type: Experimental
  description: This study concerns adults with cancer treated with chemotherapy, radiotherapy, hormonal therapy or immunotherapy, in remission or cured. Patients took part in the dedicated post-cancer assessment day. In addition, an ultrasound of the thigh is performed to measure the size of the quadriceps on 5 different measurements.
  intervention type: Other
  intervention name: JUMP group
  description: patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment
  arm group label: JUMP group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 74 Years
  healthy volunteers: No
  last name: Cyrille CONFAVREUX, Md,PhD
  phone: +33 4 78 86 12 31
  email: Cyrille.confavreux@chu-lyon.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor