<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/NCT03299270</url>
  </required_header>
  <id_info>
    <org_study_id>GOSAFE</org_study_id>
    <nct_id>NCT03299270</nct_id>
  </id_info>
  <brief_title>Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery</brief_title>
  <acronym>GOSAFE</acronym>
  <official_title>GOSAFE Study Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery An International Prospective Audit to Evaluate Postoperative Functional Outcomes and Quality of Life After Cancer Surgery in Geriatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AUSL ROMAGNA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Society of Surgical Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Society of Geriatric Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AUSL Romagna Rimini</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>
      Multicenter, international, prospective, observational study, designed to evaluate the&#xD;
      postoperative results in terms of quality of life and functional recovery of elderly patients&#xD;
      after major cancer surgery.&#xD;
&#xD;
      The global expected duration of the study is 3 years, during which cancer patients over 70&#xD;
      years old undergoing major surgery will be evaluated before and after the surgical&#xD;
      intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the&#xD;
      observational nature of the study, the original treatment plan, as designed by each&#xD;
      individual recruiting centre, will not be altered or affected by the study inclusion.&#xD;
      Inclusion in the study does not imply any deviation from the current standard of practice,&#xD;
      and no change is expected to the perioperative treatment at any point. Patients will be only&#xD;
      asked to complete simple screening/assessment tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GOSAFE study is a prospective international collaborative high-quality registry aiming to&#xD;
      gain knowledge about postoperative outcomes in older cancer patients with a particular&#xD;
      emphasis on QoL and FR. The target is to obtain meaningful data to assist clinicians in&#xD;
      tailoring the care, avoiding under/over-treatment, providing robust data to identify new&#xD;
      strategies to improve functional outcomes in older cancer patients.&#xD;
&#xD;
      Recruiting centers will collect data prospectively. Recruited patients will be followed for 6&#xD;
      months after their surgery.&#xD;
&#xD;
      The original treatment plan, as designed by each individual recruiting centre, will not be&#xD;
      altered or affected by the study inclusion.&#xD;
&#xD;
      Centers should ensure that they would make every possible effort to include all consecutive&#xD;
      eligible patients during the study period and provide completeness of data entry to ensure a&#xD;
      'real-life' study.&#xD;
&#xD;
      Patients both gender, both gender, aged ≥70, affected by solid malignancy undergoing elective&#xD;
      major surgical procedures with curative or palliative intent are eligible.&#xD;
&#xD;
      Inclusion in the study does not imply any deviation from the current standard of practice,&#xD;
      and no change is expected to the perioperative treatment at any point. Patients will be only&#xD;
      asked to complete simple screening/assessment tests.&#xD;
&#xD;
      For every eligible patient, demographic data will be collected at baseline followed by a fast&#xD;
      preoperative functional assessment. Data regarding surgical procedures and perioperative&#xD;
      measures will be collected. Complications will be reported and graded according to&#xD;
      Clavien-Dindo Classification. Three- and six-month follow up data will be collected after&#xD;
      surgery within a range of 2 weeks from the due date.&#xD;
&#xD;
      The Full Analysis Set (FAS) consists of all registered patients. The primary endpoint will be&#xD;
      measured for all registered subjects who fulfill preoperative and postoperative EQ VAS.&#xD;
      Demographic and baseline patient characteristics will be summarized for all patients in the&#xD;
      FAS. Continuous-scaled variables (e.g., age) will be summarized with means, medians, standard&#xD;
      deviations, quartiles, and minimum and maximum values. Categorical variables (e.g., sex) will&#xD;
      be summarized using patient counts and percentages. Study endpoints and variables will be&#xD;
      evaluated using descriptive statistics, and the key figures of the distributions will be&#xD;
      presented in tables. Univariate analyses will allow for a first overview of potentially&#xD;
      influential factors.&#xD;
&#xD;
      Multiple linear regression models will be performed in order to evaluate predictors of&#xD;
      functional recovery at 3 months and 6 months after surgery.&#xD;
&#xD;
      Exploratory subgroup analyses will be performed. Missing values will be replaced and&#xD;
      estimated using multiple imputations. Furthermore, sensitivity analysis will be executed&#xD;
      using complete-case analysis.&#xD;
&#xD;
      A sample size of 265 patients who completed pre and postoperative EQ VAS questionnaires will&#xD;
      have a 90% power to detect an effect size of 0,2 between pre and post surgery ,using a paired&#xD;
      t-test with a 0,05 two sided significance level.&#xD;
&#xD;
      Given a potential loss to follow-up (about 10%), uncompleted questionnaires (about 10%) and&#xD;
      postoperative mortality (about 15%), the sample size will be increased to 350-400 patients&#xD;
      (see ref 18 and 19).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Quality of Life (QoL)</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate the effects of surgery on patients' life perception by comparing pre- and post-operative QoL in elderly patients undergoing major surgery for solid malignancies using a self-reported Quality of Life assessment tool</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional recovery (FR)</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate 3 and 6 months postoperative morbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate 3 and 6 months postoperative mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic factors</measure>
    <time_frame>6 months</time_frame>
    <description>To obtain prognostic factors for postoperative functional recovery which will assist in the treatment planning /intervention of future elderly patients who are offered surgery for cancer</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1004</enrollment>
  <condition>Elderly</condition>
  <condition>Solid Malignancy</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Elderly patiences with solid malignancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Quality of Life and Functional recovery questionnaires</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Centers should ensure that they would make every possible effort to include all consecutive&#xD;
        eligible patients during the study period and provide completeness of data entry to ensure&#xD;
        a 'real-life' study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All consecutive patients, both gender, aged ≥70&#xD;
&#xD;
          2. Patients affected by solid malignancy&#xD;
&#xD;
          3. Patients undergoing elective major surgical procedures with curative or palliative&#xD;
             intent (all major procedures including any resection, for any cancer, via any&#xD;
             operative approach, open, laparoscopic, robotic, etc…)&#xD;
&#xD;
          4. Informed consent obtainment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing emergent/urgent surgical procedures&#xD;
&#xD;
          2. Planned hospital stay less than 48 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giampaolo Giampaolo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUSL Romagna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvenia Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roger William Medical Centre</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical School, Aristotle University of Thessaloniki</name>
      <address>
        <city>Thessaloníki</city>
        <zip>54248</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4592500</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Forlì</name>
      <address>
        <city>Forlì</city>
        <state>Forli-Cesena</state>
        <zip>47121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Andrea</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Desio</name>
      <address>
        <city>Desio</city>
        <state>Monza E Brianza</state>
        <zip>20039</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Matteo degli Infermi</name>
      <address>
        <city>Spoleto</city>
        <state>Perugia</state>
        <zip>06049</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IstitutoTumori Giovanni Paolo II</name>
      <address>
        <city>Bari</city>
        <state>Puglia</state>
        <zip>70121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Surgery Unit</name>
      <address>
        <city>Faenza</city>
        <state>Ravenna</state>
        <zip>48018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Riccione</name>
      <address>
        <city>Riccione</city>
        <state>Rimini</state>
        <zip>47838</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Piacenza</name>
      <address>
        <city>Piacenza</city>
        <zip>29121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica S. Rita</name>
      <address>
        <city>Vercelli</city>
        <zip>13100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groeningen University Hospital</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of clinical medicine</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jagiellonian University Medical College</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Surgery dept,Hospital Sao Francisco Xavier (CHLO)</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade Local de Saúde do Litoral Alentejano (ULSLA)</name>
      <address>
        <city>Santiago do Cacém</city>
        <zip>7500</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Miguel Hernández. Elche. Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46700</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Surgical Oncology - St. Helens Hospital of Liverpool</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester Royal Infirmary, University of Manchester</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>AUSL Romagna Rimini</investigator_affiliation>
    <investigator_full_name>AUSL ROMAGNA</investigator_full_name>
    <investigator_title>Azienda USL della Romagna</investigator_title>
  </responsible_party>
  <keyword>Surgery</keyword>
  <keyword>Solid malignancy</keyword>
  <keyword>Elderly</keyword>
  <keyword>Functional recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03299270
org study id: GOSAFE
nct id: NCT03299270
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multicenter, international, prospective, observational study, designed to evaluate the
      postoperative results in terms of quality of life and functional recovery of elderly patients
      after major cancer surgery.

      The global expected duration of the study is 3 years, during which cancer patients over 70
      years old undergoing major surgery will be evaluated before and after the surgical
      intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the
      observational nature of the study, the original treatment plan, as designed by each
      individual recruiting centre, will not be altered or affected by the study inclusion.
      Inclusion in the study does not imply any deviation from the current standard of practice,
      and no change is expected to the perioperative treatment at any point. Patients will be only
      asked to complete simple screening/assessment tests.
GOSAFE study is a prospective international collaborative high-quality registry aiming to
      gain knowledge about postoperative outcomes in older cancer patients with a particular
      emphasis on QoL and FR. The target is to obtain meaningful data to assist clinicians in
      tailoring the care, avoiding under/over-treatment, providing robust data to identify new
      strategies to improve functional outcomes in older cancer patients.

      Recruiting centers will collect data prospectively. Recruited patients will be followed for 6
      months after their surgery.

      The original treatment plan, as designed by each individual recruiting centre, will not be
      altered or affected by the study inclusion.

      Centers should ensure that they would make every possible effort to include all consecutive
      eligible patients during the study period and provide completeness of data entry to ensure a
      'real-life' study.

      Patients both gender, both gender, aged ≥70, affected by solid malignancy undergoing elective
      major surgical procedures with curative or palliative intent are eligible.

      Inclusion in the study does not imply any deviation from the current standard of practice,
      and no change is expected to the perioperative treatment at any point. Patients will be only
      asked to complete simple screening/assessment tests.

      For every eligible patient, demographic data will be collected at baseline followed by a fast
      preoperative functional assessment. Data regarding surgical procedures and perioperative
      measures will be collected. Complications will be reported and graded according to
      Clavien-Dindo Classification. Three- and six-month follow up data will be collected after
      surgery within a range of 2 weeks from the due date.

      The Full Analysis Set (FAS) consists of all registered patients. The primary endpoint will be
      measured for all registered subjects who fulfill preoperative and postoperative EQ VAS.
      Demographic and baseline patient characteristics will be summarized for all patients in the
      FAS. Continuous-scaled variables (e.g., age) will be summarized with means, medians, standard
      deviations, quartiles, and minimum and maximum values. Categorical variables (e.g., sex) will
      be summarized using patient counts and percentages. Study endpoints and variables will be
      evaluated using descriptive statistics, and the key figures of the distributions will be
      presented in tables. Univariate analyses will allow for a first overview of potentially
      influential factors.

      Multiple linear regression models will be performed in order to evaluate predictors of
      functional recovery at 3 months and 6 months after surgery.

      Exploratory subgroup analyses will be performed. Missing values will be replaced and
      estimated using multiple imputations. Furthermore, sensitivity analysis will be executed
      using complete-case analysis.

      A sample size of 265 patients who completed pre and postoperative EQ VAS questionnaires will
      have a 90% power to detect an effect size of 0,2 between pre and post surgery ,using a paired
      t-test with a 0,05 two sided significance level.

      Given a potential loss to follow-up (about 10%), uncompleted questionnaires (about 10%) and
      postoperative mortality (about 15%), the sample size will be increased to 350-400 patients
      (see ref 18 and 19).
observational model: Cohort
time perspective: Prospective
measure: Quality of Life (QoL)
time frame: 6 months
description: To evaluate the effects of surgery on patients' life perception by comparing pre- and post-operative QoL in elderly patients undergoing major surgery for solid malignancies using a self-reported Quality of Life assessment tool
measure: Functional recovery (FR)
time frame: 6 months
description: To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status
measure: Morbidity
time frame: 6 months
description: To evaluate 3 and 6 months postoperative morbidity
measure: Mortality
time frame: 6 months
description: To evaluate 3 and 6 months postoperative mortality
measure: Prognostic factors
time frame: 6 months
description: To obtain prognostic factors for postoperative functional recovery which will assist in the treatment planning /intervention of future elderly patients who are offered surgery for cancer
arm group label: Group 1
description: Elderly patiences with solid malignancy
intervention type: Other
intervention name: Questionnaires
description: Quality of Life and Functional recovery questionnaires
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Giampaolo Giampaolo, MD
role: Principal Investigator
affiliation: AUSL Romagna
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Greece
country: Israel
country: Italy
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: AUSL Romagna Rimini
investigator full name: AUSL ROMAGNA
investigator title: Azienda USL della Romagna
mesh term: Neoplasms