<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/NCT02249013</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1158-0472</org_study_id>
    <secondary_id>18388113.4.0000.5201</secondary_id>
    <nct_id>NCT02249013</nct_id>
  </id_info>
  <brief_title>Short-course HIPEC in Advanced Epithelial Ovarian Cancer</brief_title>
  <official_title>Short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Debulking Surgery for High Tumor Burden Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professor Fernando Figueira Integral Medicine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Câncer de Pernambuco (Recife/PE)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AC Camargo Cancer Center (São Paulo/SP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Brasileiro de Controle do Câncer (São Paulo/SP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Cancer de Barretos - Fundacao Pio XII (Barretos/SP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Sao Jose (Criciuma/SC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Base do Distrito Federal (Brasilia/DF)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Professor Fernando Figueira Integral Medicine Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and&#xD;
      efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy&#xD;
      (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant&#xD;
      chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was initially designed to explore the safety and efficacy of short-course HIPEC in&#xD;
      terms of median progression-free survival (PFS) as the primary outcome. However, due to slow&#xD;
      accrual, the design was subsequently amended to explore the primary outcome measure of PD9&#xD;
      (i.e.: proportion of patients with disease progression or death occurring within 9 months of&#xD;
      IDS plus HIPEC). The hypothesis was the short-course HIPEC could decrease PD9 with low rates&#xD;
      of morbidity and mortality. In these settings, we explore a comprehensive treatment approach&#xD;
      involving fast-track advanced cytoreductive surgery (CRS) plus short-course HIPEC at the time&#xD;
      of IDS following NACT for high tumor burden patients with stage III-IV ovarian cancer.&#xD;
      Advanced CRS was performed with standard peritonectomy procedures and visceral resections&#xD;
      directed towards complete elimination of tumors from the abdominopelvic cavity, and&#xD;
      fast-track recovery strategies were also applied to improve patient outcomes. HIPEC was&#xD;
      performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2,&#xD;
      total limit of 240mg) or CDDP plus Doxorubicin (15mg/L) for 30 minutes, with an&#xD;
      intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was&#xD;
      circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at&#xD;
      a flow rate of 700 ml/min. Systemic chemotherapy included the standard combination of&#xD;
      carboplatin and paclitaxel as neo-adjuvant plus adjuvant regimens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">February 23, 2021</completion_date>
  <primary_completion_date type="Actual">February 23, 2021</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PD9</measure>
    <time_frame>9 months</time_frame>
    <description>Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative 30-day mortality rate</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality rates up to 30-day after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication rates</measure>
    <time_frame>30 days</time_frame>
    <description>Complications rates up to 30-day after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of life (QLQ-C30/EORTC)</measure>
    <time_frame>Baseline (i.e., at the time of hospital admission for IDS plus HIPEC); after CRS/HIPEC (i.e., at the time of restarting the systemic chemotherapy); after protocol (i.e., at 3-6 weeks after the last syst</time_frame>
    <description>Assessment of quality of life according to the QLQ-C30/EORTC scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>24 months</time_frame>
    <description>We defined OS as the time from starting the NACT to death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>24 months</time_frame>
    <description>We defined PFS as the time from starting the NACT to disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival (DFS)</measure>
    <time_frame>24 months</time_frame>
    <description>We defined DFS for patients without no gross residual disease as the time from IDS plus HIPEC to disease progression.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to start chemotherapy after surgery</measure>
    <time_frame>An expected range of 4 to 8 weeks</time_frame>
    <description>Time to start adjuvant chemotherapy after surgery (CRS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of ICU and hospital stay</measure>
    <time_frame>An expected range of 5 to 30 days</time_frame>
    <description>Length of ICU and hospital stay.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>HIPEC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neoadjuvant Chemotherapy (NACT) followed by Cytoreductive Surgery (CRS) under a Fast-track recovery strategy plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and thus, Adjuvant Chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cytoreductive Surgery (CRS)</intervention_name>
    <description>CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.</description>
    <arm_group_label>HIPEC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hyperthermic Intraperitoneal Chemotherapy (HIPEC)</intervention_name>
    <description>HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) for the first 10 patients and thus, using CDDP plus Doxorubicin (15mg/L) thereafter, both for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min.</description>
    <arm_group_label>HIPEC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neoadjuvant Chemotherapy (NACT)</intervention_name>
    <description>Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.</description>
    <arm_group_label>HIPEC</arm_group_label>
    <other_name>Carboplatin</other_name>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvant Chemotherapy</intervention_name>
    <description>Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.</description>
    <arm_group_label>HIPEC</arm_group_label>
    <other_name>Carboplatin</other_name>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fast-track recovery strategy</intervention_name>
    <description>A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.</description>
    <arm_group_label>HIPEC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               -  Patients with no previous treatment and candidates for elective surgery with&#xD;
                  histological diagnosis of epithelial ovarian carcinoma;&#xD;
&#xD;
               -  Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis;&#xD;
&#xD;
               -  No other malignancies in activity;&#xD;
&#xD;
               -  No previous treatments such as radiation, chemotherapy (except neoadjuvant&#xD;
                  chemotherapy in the study protocol) or major abdominal surgery;&#xD;
&#xD;
               -  Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy&#xD;
                  or breast feeding;&#xD;
&#xD;
               -  Aged between 18 and 70 years;&#xD;
&#xD;
               -  Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or&#xD;
                  greater than 70 points by the Karnofsky scale;&#xD;
&#xD;
               -  Appropriated cardio-respiratory, hepato-renal and hematological reserves;&#xD;
&#xD;
               -  Signing of the Consent Form.&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               -  Evidence of extensive retroperitoneal lymph node involvement or unresectable&#xD;
                  disease (i.e., massive involvement of the small bowel, mesentery, or hepatic&#xD;
                  pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC;&#xD;
&#xD;
               -  Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3);&#xD;
&#xD;
               -  Limiting obesity for CRS or HIPEC;&#xD;
&#xD;
               -  Disease progression, apparent or confirmed uncontrolled infection, or health&#xD;
                  impairment during NACT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thales P Batista, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor Fernando Figueira Integral Medicine Institute</affiliation>
  </overall_official>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5732565/</url>
    <description>The first paper describing early outcomes and insights after an interim analysis of our pioneering clinical trial in Brazil</description>
  </link>
  <link>
    <url>http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0100-69912016000600476&amp;lng=en&amp;nrm=iso&amp;tlng=en</url>
    <description>A technical note exploring the dynamic relationships between flow rates and temperature parameters in the first cases of our study.</description>
  </link>
  <results_reference>
    <citation>Batista TP, Carneiro VCG, Tancredi R, Teles ALB, Badiglian-Filho L, Leao CS. Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach. Cancer Manag Res. 2017 Dec 13;9:869-878. doi: 10.2147/CMAR.S153327. eCollection 2017.</citation>
    <PMID>29263704</PMID>
  </results_reference>
  <results_reference>
    <citation>Batista TP, Badiglian Filho L, Leao CS. Exploring flow rate selection in HIPEC procedures. Rev Col Bras Cir. 2016 Dec;43(6):476-479. doi: 10.1590/0100-69912016006014. English, Portuguese.</citation>
    <PMID>28273222</PMID>
  </results_reference>
  <results_reference>
    <citation>Lustosa RJC, Batista TP, Carneiro VCG, Badiglian-Filho L, Costa RLR, Lopes A, Sarmento BJQ, Lima JTO, Mello MJG, LeAo CS. Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer. Rev Col Bras Cir. 2020;47:e20202534. doi: 10.1590/0100-6991e-20202534. Epub 2020 Jul 10. English, Portuguese.</citation>
    <PMID>32667582</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Professor Fernando Figueira Integral Medicine Institute</investigator_affiliation>
    <investigator_full_name>Thales Paulo Batista</investigator_full_name>
    <investigator_title>Consultant Physician and Researcher</investigator_title>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We have no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </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/NCT02249013
org study id: U1111-1158-0472
secondary id: 18388113.4.0000.5201
nct id: NCT02249013
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and
      efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy
      (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant
      chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).
This study was initially designed to explore the safety and efficacy of short-course HIPEC in
      terms of median progression-free survival (PFS) as the primary outcome. However, due to slow
      accrual, the design was subsequently amended to explore the primary outcome measure of PD9
      (i.e.: proportion of patients with disease progression or death occurring within 9 months of
      IDS plus HIPEC). The hypothesis was the short-course HIPEC could decrease PD9 with low rates
      of morbidity and mortality. In these settings, we explore a comprehensive treatment approach
      involving fast-track advanced cytoreductive surgery (CRS) plus short-course HIPEC at the time
      of IDS following NACT for high tumor burden patients with stage III-IV ovarian cancer.
      Advanced CRS was performed with standard peritonectomy procedures and visceral resections
      directed towards complete elimination of tumors from the abdominopelvic cavity, and
      fast-track recovery strategies were also applied to improve patient outcomes. HIPEC was
      performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2,
      total limit of 240mg) or CDDP plus Doxorubicin (15mg/L) for 30 minutes, with an
      intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was
      circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at
      a flow rate of 700 ml/min. Systemic chemotherapy included the standard combination of
      carboplatin and paclitaxel as neo-adjuvant plus adjuvant regimens.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PD9
time frame: 9 months
description: Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC
measure: Postoperative 30-day mortality rate
time frame: 30 days
description: Mortality rates up to 30-day after surgery
measure: Postoperative complication rates
time frame: 30 days
description: Complications rates up to 30-day after surgery
measure: Assessment of quality of life (QLQ-C30/EORTC)
time frame: Baseline (i.e., at the time of hospital admission for IDS plus HIPEC); after CRS/HIPEC (i.e., at the time of restarting the systemic chemotherapy); after protocol (i.e., at 3-6 weeks after the last syst
description: Assessment of quality of life according to the QLQ-C30/EORTC scales.
measure: Overall survival (OS)
time frame: 24 months
description: We defined OS as the time from starting the NACT to death.
measure: Progression-free Survival (PFS)
time frame: 24 months
description: We defined PFS as the time from starting the NACT to disease progression.
measure: Disease-free Survival (DFS)
time frame: 24 months
description: We defined DFS for patients without no gross residual disease as the time from IDS plus HIPEC to disease progression.
measure: Time to start chemotherapy after surgery
time frame: An expected range of 4 to 8 weeks
description: Time to start adjuvant chemotherapy after surgery (CRS).
measure: Length of ICU and hospital stay
time frame: An expected range of 5 to 30 days
description: Length of ICU and hospital stay.
arm group label: HIPEC
arm group type: Experimental
description: Neoadjuvant Chemotherapy (NACT) followed by Cytoreductive Surgery (CRS) under a Fast-track recovery strategy plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and thus, Adjuvant Chemotherapy
intervention type: Procedure
intervention name: Cytoreductive Surgery (CRS)
description: CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.
arm group label: HIPEC
intervention type: Procedure
intervention name: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
description: HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) for the first 10 patients and thus, using CDDP plus Doxorubicin (15mg/L) thereafter, both for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min.
arm group label: HIPEC
intervention type: Drug
intervention name: Neoadjuvant Chemotherapy (NACT)
description: Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
arm group label: HIPEC
other name: Carboplatin
other name: Paclitaxel
intervention type: Drug
intervention name: Adjuvant Chemotherapy
description: Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
arm group label: HIPEC
other name: Carboplatin
other name: Paclitaxel
intervention type: Procedure
intervention name: Fast-track recovery strategy
description: A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.
arm group label: HIPEC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Thales P Batista, MD, MS
role: Principal Investigator
affiliation: Professor Fernando Figueira Integral Medicine Institute
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5732565/
description: The first paper describing early outcomes and insights after an interim analysis of our pioneering clinical trial in Brazil
url: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-69912016000600476&lng=en&nrm=iso&tlng=en
description: A technical note exploring the dynamic relationships between flow rates and temperature parameters in the first cases of our study.
citation: Batista TP, Carneiro VCG, Tancredi R, Teles ALB, Badiglian-Filho L, Leao CS. Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach. Cancer Manag Res. 2017 Dec 13;9:869-878. doi: 10.2147/CMAR.S153327. eCollection 2017.
PMID: 29263704
citation: Batista TP, Badiglian Filho L, Leao CS. Exploring flow rate selection in HIPEC procedures. Rev Col Bras Cir. 2016 Dec;43(6):476-479. doi: 10.1590/0100-69912016006014. English, Portuguese.
PMID: 28273222
citation: Lustosa RJC, Batista TP, Carneiro VCG, Badiglian-Filho L, Costa RLR, Lopes A, Sarmento BJQ, Lima JTO, Mello MJG, LeAo CS. Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer. Rev Col Bras Cir. 2020;47:e20202534. doi: 10.1590/0100-6991e-20202534. Epub 2020 Jul 10. English, Portuguese.
PMID: 32667582
responsible party type: Principal Investigator
investigator affiliation: Professor Fernando Figueira Integral Medicine Institute
investigator full name: Thales Paulo Batista
investigator title: Consultant Physician and Researcher
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Carboplatin
sharing ipd: No
ipd description: We have no plan to make individual participant data (IPD) available to other researchers.