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/NCT05966909</url>
    </required_header>
    <id_info>
      <org_study_id>THROMBPICC</org_study_id>
      <nct_id>NCT05966909</nct_id>
    </id_info>
    <brief_title>Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients</brief_title>
    <official_title>Asymptomatic PICC-related Thrombosis in Cancer Patients: a Prospective Cohort Study of an Ultrasound-guided Approach.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Azienda Ospedaliera Universitaria Integrata Verona</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>
        In this prospective cohort study, the investigators evaluated the incidence of superficial&#xD;
        vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation in solid cancer&#xD;
        patients undergoing chemotherapy. The study aimed to shed light on the clinical progression&#xD;
        of venous thrombosis in cancer patients with central venous catheters, with a particular&#xD;
        focus on certain cancer types associated with a higher risk of venous thromboembolism (VTE).&#xD;
  &#xD;
        The investigators believe that such findings hold significant clinical relevance as a&#xD;
        substantial portion of the study population was affected by pancreatic cancer, a cancer type&#xD;
        known to carry a high risk of thrombotic events. This research adds valuable insights into&#xD;
        understanding asymptomatic PICC-related thrombosis in this specific subgroup of cancer&#xD;
        patients, which can aid in developing effective management strategies for venous access in&#xD;
        this challenging population.&#xD;
  &#xD;
        The study employed an ultrasound-guided approach for follow-up at 30 and 90 days after&#xD;
        catheter insertion, enabling us to detect and treat asymptomatic PICC-VTE in a timely manner.&#xD;
        Identifying independent risk factors for catheter-related thrombosis, including age and&#xD;
        cancer type, has further enhanced the clinical applicability of our findings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Managing venous access in cancer patients is challenging, and peripherally inserted central&#xD;
        catheter-ports (PICC-ports) have emerged as a promising option for safety and efficacy.&#xD;
        However, understanding the clinical progression of venous thrombosis in cancer patients with&#xD;
        central venous catheters remains limited, especially in certain cancer types associated with&#xD;
        a higher risk of venous thromboembolism (VTE).&#xD;
  &#xD;
        In this prospective cohort study of solid cancer patients receiving chemotherapy, the&#xD;
        investigators will evaluate the incidence of superficial vein thrombosis, deep vein&#xD;
        thrombosis, and fibroblastic sleeve formation through ultrasound follow-up at 30 and 90 days&#xD;
        after catheter insertion. The investigators will analyze clinical factors associated with&#xD;
        PICC-related VTE (PICC-VTE) and compare incidence rates between PICC-ports and traditional&#xD;
        PICCs.&#xD;
  &#xD;
        Ultrasound follow-up is valuable for detecting asymptomatic PICC-VTE, enabling timely and&#xD;
        effective initiation of therapy, especially in elderly patients and those with high-risk&#xD;
        thrombotic cancers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</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>Catheter related thrombosis</measure>
      <time_frame>1 month and 3 months from baseline</time_frame>
      <description>Symptomatic and asymptomatic upper extremities thrombosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PICC vs PICC-PORT</measure>
      <time_frame>1 month and 3 months from baseline</time_frame>
      <description>Risk factors associated with Catheter related Thrombosis</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">120</enrollment>
    <condition>Catheter Related Complication</condition>
    <arm_group>
      <arm_group_label>Solid cancer patients</arm_group_label>
      <description>Patients with solid cancer who underwent the placement of a PICC or PICC-PORT for chemotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Doppler Ultrasound</intervention_name>
      <description>Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis</description>
      <arm_group_label>Solid cancer patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with solid cancer undergoing chemotherapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with:&#xD;
  &#xD;
                 1. a documented active malignancy;&#xD;
  &#xD;
                 2. PICC or PORT placement for systemic chemotherapy;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with:&#xD;
  &#xD;
                 1. a communication disorder;&#xD;
  &#xD;
                 2. contraindications to anticoagulation therapy;&#xD;
  &#xD;
                 3. hematopathy;&#xD;
  &#xD;
                 4. expected survival of less than one month;&#xD;
  &#xD;
                 5. were lost to follow-up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mattia Cominacini, MD</last_name>
      <role>Study Director</role>
      <affiliation>Azienda Ospedaliera Universitaria Integrata Verona</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Azienda Ospedaliera Universitaria Integrata</name>
        <address>
          <city>Verona</city>
          <zip>37134</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Ospedaliera Universitaria Integrata Verona</investigator_affiliation>
      <investigator_full_name>Luca Giuseppe Dalle Carbonare</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Catheter-related thrombosis</keyword>
    <keyword>Peripherally inserted central catheter-ports</keyword>
    <keyword>Cancer associated thrombosis</keyword>
    <keyword>Upper extremities vein thrombosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05966909
  org study id: THROMBPICC
  nct id: NCT05966909
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this prospective cohort study, the investigators evaluated the incidence of superficial
        vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation in solid cancer
        patients undergoing chemotherapy. The study aimed to shed light on the clinical progression
        of venous thrombosis in cancer patients with central venous catheters, with a particular
        focus on certain cancer types associated with a higher risk of venous thromboembolism (VTE).
  
        The investigators believe that such findings hold significant clinical relevance as a
        substantial portion of the study population was affected by pancreatic cancer, a cancer type
        known to carry a high risk of thrombotic events. This research adds valuable insights into
        understanding asymptomatic PICC-related thrombosis in this specific subgroup of cancer
        patients, which can aid in developing effective management strategies for venous access in
        this challenging population.
  
        The study employed an ultrasound-guided approach for follow-up at 30 and 90 days after
        catheter insertion, enabling us to detect and treat asymptomatic PICC-VTE in a timely manner.
        Identifying independent risk factors for catheter-related thrombosis, including age and
        cancer type, has further enhanced the clinical applicability of our findings.
  Managing venous access in cancer patients is challenging, and peripherally inserted central
        catheter-ports (PICC-ports) have emerged as a promising option for safety and efficacy.
        However, understanding the clinical progression of venous thrombosis in cancer patients with
        central venous catheters remains limited, especially in certain cancer types associated with
        a higher risk of venous thromboembolism (VTE).
  
        In this prospective cohort study of solid cancer patients receiving chemotherapy, the
        investigators will evaluate the incidence of superficial vein thrombosis, deep vein
        thrombosis, and fibroblastic sleeve formation through ultrasound follow-up at 30 and 90 days
        after catheter insertion. The investigators will analyze clinical factors associated with
        PICC-related VTE (PICC-VTE) and compare incidence rates between PICC-ports and traditional
        PICCs.
  
        Ultrasound follow-up is valuable for detecting asymptomatic PICC-VTE, enabling timely and
        effective initiation of therapy, especially in elderly patients and those with high-risk
        thrombotic cancers.
  observational model: Cohort
  time perspective: Prospective
  measure: Catheter related thrombosis
  time frame: 1 month and 3 months from baseline
  description: Symptomatic and asymptomatic upper extremities thrombosis
  measure: PICC vs PICC-PORT
  time frame: 1 month and 3 months from baseline
  description: Risk factors associated with Catheter related Thrombosis
  arm group label: Solid cancer patients
  description: Patients with solid cancer who underwent the placement of a PICC or PICC-PORT for chemotherapy.
  intervention type: Diagnostic Test
  intervention name: Doppler Ultrasound
  description: Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis
  arm group label: Solid cancer patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  last name: Mattia Cominacini, MD
  role: Study Director
  affiliation: Azienda Ospedaliera Universitaria Integrata Verona
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Ospedaliera Universitaria Integrata Verona
  investigator full name: Luca Giuseppe Dalle Carbonare
  investigator title: Associate Professor
  mesh term: Thrombosis
  sharing ipd: No