<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/NCT04478916</url>
  </required_header>
  <id_info>
    <org_study_id>ONCO-AGING</org_study_id>
    <nct_id>NCT04478916</nct_id>
  </id_info>
  <brief_title>Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients</brief_title>
  <acronym>ONCO-AGING</acronym>
  <official_title>Impact of the Comprehensive Geriatric Assessment on the Quality of Life of Elderly Onco-hematologic Patients' Candidates for Complex Antitumoral Therapies: Clinical and Biological Correlatives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lorenza Scotti</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Eastern Piedmont</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>
      Impact of the Comprehensive Geriatric Assessment on the Quality of Life of elderly&#xD;
      onco-hematologic patients' candidates for complex antitumoral therapies: clinical and&#xD;
      biological correlatives&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The screenings for the next 2 decades indicate an exponential increase in the incidence of&#xD;
      neoplastic diseases in the elderly population. In order to successfully balance effectiveness&#xD;
      and low toxicity of immunochemotherapy, a treatment personalisation based on an objective&#xD;
      evaluation of fitness is therefore needed. The use of geriatric screening is a first step to&#xD;
      rationalize decisions in this regard, the G8 tool has demonstrated the ability to identify&#xD;
      patients and mostly to objectively separate elderly fragile patients from those who are fit.&#xD;
      In that consideration, the individualization of the anticancer treatment based on a&#xD;
      Comprehensive Geriatric Assessment (CGA) is desirable in elderly fragile patients with solid&#xD;
      or haematological malignancy. Cancer mortality is constantly increasing after 65 years and&#xD;
      the consequent increase in life expectancy favour the processes of cellular senescence. In&#xD;
      this context G8 fragility assessment will take place in the screening test and by using the&#xD;
      EORTC QLQ-C30C questionnaire to assess quality of life (QoL). The evaluation of senescent&#xD;
      cells will be done by real-time PCR. Our aims are i) to evaluate the impact of the CGA on the&#xD;
      QoL of elderly onco-haematological patients, candidates for complex therapies, that resulted&#xD;
      as fragile at the G8 geriatric screening and ii) to evaluate the senescent cells in the&#xD;
      peripheral blood of the patients enrolled in the study. The study is expected to contribute&#xD;
      to precision medicine management of elderly patients and refine the therapeutic&#xD;
      stratifications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 18, 2019</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)</measure>
    <time_frame>12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)</time_frame>
    <description>To assess the impact of the inclusion of the CGA on the quality of life (QOL) of the elderly onco-hematology patient that result frail in the geriatric screening (G8), compared to the clinical practice that does not include the CGA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)</measure>
    <time_frame>12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)</time_frame>
    <description>Part of patients receiving radiotherapy will be randomised to be evaluated using CGA compared to control group, the CGA assessment will be done using the status of ADL, IADL, QOL, MNA, SVI, GDS, CIRS, TC, MMSE, CDT, MOCA, RFI, VMD, at baseline and would be re-evaluated after every 6 month and If necessary, an onco-geriatric follow-up will be carried out, for the re-evaluation and further correction of the areas of fragility. A description of the changes of the above scales would also be recorded for the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>From randomisation (December 2019-December 2022)</time_frame>
    <description>Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure Free Survival (FFS)</measure>
    <time_frame>From randomisation (December 2019-December 2022)</time_frame>
    <description>Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of dose reductions</measure>
    <time_frame>From randomisation through study completion, an average of 1 year</time_frame>
    <description>Data will be collected by reviewing patients medical charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomisation (December 2019-December 2022)</time_frame>
    <description>From the date of diagnosis to the last patient last visit</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Senescent cells role in interfering with the planned therapy</measure>
    <time_frame>2019-From randomisation until 12 months or until disease progression</time_frame>
    <description>Senescent cells levels and their role in interfering with the planned therapy and the outcome of disease prognosis, PFS, OS. and the correlation between senescent cells level with the results of patients QOL, CGA and G8</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Hematologic Malignancies</condition>
  <condition>Solid Tumor</condition>
  <condition>Elderly Patients</condition>
  <arm_group>
    <arm_group_label>Geriatric evaluation Group</arm_group_label>
    <description>Geriatric evaluation of the proportion of elderly patients in which the treatment is modified based on the complete geriatric assessment (CGA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The study is designed to evaluate the senescent cells and MDSC; in the peripheral blood of&#xD;
      the patients enrolled in the project in 2 time-points: first on basal line (t = 0) and after&#xD;
      12 months or in disease progression. Blood samples (10 ml whole blood) will be collected in&#xD;
      Vacutainer EDTA tubes.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In the present study, only patients aged ≥ 65 years, with diagnosis of solid or hematologic&#xD;
        cancer are eligible. Main inclusion criteria are two; i) patients who are candidates for a&#xD;
        first line therapy for advanced disease to be treated with biological target drugs, or&#xD;
        candidates for integrated radiotherapy; ii) patient with G8 scores ≤ 14/17&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥ 65 years&#xD;
&#xD;
          -  Diagnosis of solid or hematologic cancer&#xD;
&#xD;
          -  Patients who are candidates for a first line therapy for advanced disease to be&#xD;
             treated with biological target drugs, or candidates for integrated radiotherapy&#xD;
&#xD;
          -  Patient with G8 scores ≤ 14/17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 65 years&#xD;
&#xD;
          -  Patients who have received or currently in treatment for solid or hematologic cancer&#xD;
&#xD;
          -  Patient with G8 scores more than 14/17&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Alessandra Gennari</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Translational Medicine, Università del Piemonte Orientale</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Prof. Alessandra Gennari</last_name>
    <phone>+39 0321 3732292</phone>
    <email>alessandra.gennari@med.uniupo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Università del Piemonte Orientale - Azienda Ospedliero-Universitaria Maggiore della Carita'</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Alessandra Gennari</last_name>
      <phone>+39 0321 3732292</phone>
      <email>alessandra.gennari@med.uniupo.it</email>
    </contact>
    <investigator>
      <last_name>Prof. Alessandra Gennari</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Prof. Gianluca Gaidano</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Prof. Marco Krengli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Eastern Piedmont</investigator_affiliation>
    <investigator_full_name>Lorenza Scotti</investigator_full_name>
    <investigator_title>Statistician</investigator_title>
  </responsible_party>
  <keyword>Onco-hematologic diseases</keyword>
  <keyword>Comprehensive Geriatric Assessment (CGA)</keyword>
  <keyword>Screening tool G8</keyword>
  <keyword>Geriatric Medicine</keyword>
  <keyword>Precision Medicine</keyword>
  <keyword>Senescence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic 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/NCT04478916
org study id: ONCO-AGING
nct id: NCT04478916
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Impact of the Comprehensive Geriatric Assessment on the Quality of Life of elderly
      onco-hematologic patients' candidates for complex antitumoral therapies: clinical and
      biological correlatives
The screenings for the next 2 decades indicate an exponential increase in the incidence of
      neoplastic diseases in the elderly population. In order to successfully balance effectiveness
      and low toxicity of immunochemotherapy, a treatment personalisation based on an objective
      evaluation of fitness is therefore needed. The use of geriatric screening is a first step to
      rationalize decisions in this regard, the G8 tool has demonstrated the ability to identify
      patients and mostly to objectively separate elderly fragile patients from those who are fit.
      In that consideration, the individualization of the anticancer treatment based on a
      Comprehensive Geriatric Assessment (CGA) is desirable in elderly fragile patients with solid
      or haematological malignancy. Cancer mortality is constantly increasing after 65 years and
      the consequent increase in life expectancy favour the processes of cellular senescence. In
      this context G8 fragility assessment will take place in the screening test and by using the
      EORTC QLQ-C30C questionnaire to assess quality of life (QoL). The evaluation of senescent
      cells will be done by real-time PCR. Our aims are i) to evaluate the impact of the CGA on the
      QoL of elderly onco-haematological patients, candidates for complex therapies, that resulted
      as fragile at the G8 geriatric screening and ii) to evaluate the senescent cells in the
      peripheral blood of the patients enrolled in the study. The study is expected to contribute
      to precision medicine management of elderly patients and refine the therapeutic
      stratifications.
observational model: Cohort
time perspective: Prospective
measure: Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)
time frame: 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)
description: To assess the impact of the inclusion of the CGA on the quality of life (QOL) of the elderly onco-hematology patient that result frail in the geriatric screening (G8), compared to the clinical practice that does not include the CGA
measure: Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)
time frame: 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)
description: Part of patients receiving radiotherapy will be randomised to be evaluated using CGA compared to control group, the CGA assessment will be done using the status of ADL, IADL, QOL, MNA, SVI, GDS, CIRS, TC, MMSE, CDT, MOCA, RFI, VMD, at baseline and would be re-evaluated after every 6 month and If necessary, an onco-geriatric follow-up will be carried out, for the re-evaluation and further correction of the areas of fragility. A description of the changes of the above scales would also be recorded for the patients
measure: Progression free survival (PFS)
time frame: From randomisation (December 2019-December 2022)
description: Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause
measure: Failure Free Survival (FFS)
time frame: From randomisation (December 2019-December 2022)
description: Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause
measure: Occurrence of dose reductions
time frame: From randomisation through study completion, an average of 1 year
description: Data will be collected by reviewing patients medical charts
measure: Overall Survival (OS)
time frame: From randomisation (December 2019-December 2022)
description: From the date of diagnosis to the last patient last visit
measure: Senescent cells role in interfering with the planned therapy
time frame: 2019-From randomisation until 12 months or until disease progression
description: Senescent cells levels and their role in interfering with the planned therapy and the outcome of disease prognosis, PFS, OS. and the correlation between senescent cells level with the results of patients QOL, CGA and G8
arm group label: Geriatric evaluation Group
description: Geriatric evaluation of the proportion of elderly patients in which the treatment is modified based on the complete geriatric assessment (CGA)
arm group label: Control Group
The study is designed to evaluate the senescent cells and MDSC; in the peripheral blood of
      the patients enrolled in the project in 2 time-points: first on basal line (t = 0) and after
      12 months or in disease progression. Blood samples (10 ml whole blood) will be collected in
      Vacutainer EDTA tubes.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Prof. Alessandra Gennari
role: Principal Investigator
affiliation: Department of Translational Medicine, Università del Piemonte Orientale
last name: Prof. Alessandra Gennari
phone: +39 0321 3732292
email: alessandra.gennari@med.uniupo.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: University of Eastern Piedmont
investigator full name: Lorenza Scotti
investigator title: Statistician
mesh term: Hematologic Neoplasms