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/NCT06030869</url>
    </required_header>
    <id_info>
      <org_study_id>MyCustom for Solid Tumors</org_study_id>
      <nct_id>NCT06030869</nct_id>
    </id_info>
    <brief_title>MyCustom:Prospective Master Protocol Trial on Precision Medicine Treatment for Refractory Solid Tumors</brief_title>
    <official_title>MyCustom:A Framework for Prospective and Master Protocol Trial of Precise Drug Treatment for Refractory Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Second Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Second Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical&#xD;
        research project, a genetic biomarker-driven &quot;basket&quot; (tissue-type agonistic) study. The&#xD;
        target population covers a variety of solid advanced malignant tumors, including but not&#xD;
        limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck&#xD;
        squamous carcinoma or lacking effective treatment after standard treatment failure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical&#xD;
        research project, a genetic biomarker-driven &quot;basket&quot; (tissue-type agonistic) study. The&#xD;
        target population covers a variety of solid advanced malignant tumors, including but not&#xD;
        limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck&#xD;
        squamous carcinoma or lacking effective treatment after standard treatment failure.The&#xD;
        overall goal is to develop a more effective research method to test new individualized&#xD;
        treatment hypotheses.This study will provide comprehensive theoretical and practical support&#xD;
        for individualized custom model in refractory solid tumors.Archival pathology laboratory&#xD;
        samples from patients with treatment-refractory advanced solid cancer of any histologic type&#xD;
        undergo Next Gene Sequencing(NGS) analysis.Fllowing obtain the raw data of the patient's gene&#xD;
        sequencing, the data are analyzed by the auxiliary decision algorithm to obtain the&#xD;
        prioritization results of the drugs matched by this patient.The results are subsequently&#xD;
        reviewed by the Molecular Tumor Board (MTB), where eligible patients can be treated in&#xD;
        treatment substudies.All patients who receive treatment with a drug available in the protocol&#xD;
        will be followed for standard efficacy outcomes including clinical efficacy ,clinical safety&#xD;
        and exploratory endpoints such as biomarkers for drug response, change in the tumor&#xD;
        microenvironment. For some clinical studies, to meet the primary objective, at least 35% of&#xD;
        participants had to achieve a PF2S/PFS1 ≥ 1.3 in a sample population of 25 evaluable&#xD;
        patients. sample size was calculated using an exact single-stage design for phase II studies&#xD;
        with a one-sided type I error of 5% and a power of 90% under the assumption that PF2S/PFS1≥&#xD;
        1.3 in ≤10% of patients would be clinically irrelevant, while a success rate ≥ 35% would&#xD;
        merit further investigation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2020</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)</measure>
      <time_frame>3 years</time_frame>
      <description>The time to progression-free survival during the substudy (PFS2) exceeds the documented time to disease progression-free survival during the last treatment prior to substudy entry (PFS1) by at least 35% (ie, PFS2/PFS1≥1.3) or, if PFS1 is not evaluable, time to progressive disease exceeds 6 months.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ORR(Objective Response Rate)</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS(Overall Survival)</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0</measure>
      <time_frame>3 years</time_frame>
      <description>Treatment related adverse events with grade 3 or greater severity by CTCAE 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with actionable target</measure>
      <time_frame>3 years</time_frame>
      <description>Number of patients with modifiable genomic variants.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Refractory Solid Tumors</condition>
    <condition>Next Generation Sequencing</condition>
    <arm_group>
      <arm_group_label>Cohort-A: Patients with actionable targets</arm_group_label>
      <description>In the OncoKB(Precision Oncology Knowledge Base) database, the gene alteration has a variant of clinical evidence in this tumor or other tumor types and is considered to be an interventional variant. Cohort-A may include different observation subgroups. For example, substudy-A1: monotherapy/combination therapy for patients with A1-relative. Substudy-Ax: monotherapy/combination therapy for patients with Ax-relative.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort-B: Patients with potential actionable targets</arm_group_label>
      <description>In cohort-B, the gene alteration that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets. Cohort-B also includes different observation subgroups and clinical trials may conduct in each subgroup. For example, substudy-B1(TP53 as driver gene), substudy-B2(RAS as driver gene), substudy-B3(MAP2K1 as driver gene), substudy-B4(PTEN Loss as driver gene), substudy-B5(11q13 co-amplification as driver genes), Substudy-B6(concomitant actionable alterations), substudy-B7(other driver genes). MTB-guided therapy was defined as having a clinical benefit if the PFS ratio between the longest PFS on MTB-guided therapy and the PFS on the last therapy before MTB-guided therapy was ≥1.3 (i.e., using patients as their own controls) for each substudy. To meet the primary objective, at least 35% of participants had to achieve a PF2S/PFS1 ≥ 1.3 in a sample population of 25 evaluable patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort-C: Patients with non-actionable targets</arm_group_label>
      <description>MTB combined with clinical practice and literature reports can not match the gene alteration of targeted therapy, which is considered as an irreversible gene alteration.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Eligible patients have an advanced or metastatic solid tumor, multiple cancers(including&#xD;
          but not limited to small cell lung cancer, gastric cancer, prostate cancer, bladder cancer,&#xD;
          and head and neck squamous cell carcinoma) standard treatment options are no longer&#xD;
          available or lack effective treatments.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults(≥18 years of age)with pathologically confirmed advanced or metastatic solid&#xD;
               cancer of any histological type, or an earlier diagnosis of cancer with a poor&#xD;
               prognosis. Suffificient accessible tissue for molecular profifiling;&#xD;
  &#xD;
            2. Patients receiving their last line of standard treatment or who have received and&#xD;
               failed all standard anticancer therapy (if available) or are unsuitable for further&#xD;
               standard anticancer therapy. Cancers with a poor prognosis or low expected response&#xD;
               rate to standard treatment (as judged by the investigator on the basis of available&#xD;
               evidence) may be screened with respect to an earlier line of treatment;&#xD;
  &#xD;
            3. ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4));&#xD;
  &#xD;
            4. Willing and potentially able to comply with study requirements,including treatment,&#xD;
               timing and nature of required assessments;&#xD;
  &#xD;
            5. Signed, written informed consent to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Suitable for standard therapy;&#xD;
  &#xD;
            2. Specific contraindications to exposure to the investigationalproducts;&#xD;
  &#xD;
            3. Other comorbid conditions that may compromise assessing key outcomes or, in the&#xD;
               judgement of the clinician, limit the ability of the patient to comply with the&#xD;
               protocol;&#xD;
  &#xD;
            4. Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a&#xD;
               non-central cancer;&#xD;
  &#xD;
            5. Pregnancy, lactation or inadequate contraception.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Haitao Wang, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Medical University Second Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Haitao Wang, Ph.D</last_name>
      <phone>+86-022-88326610</phone>
      <email>peterrock2000@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lili Wang, M. Med.</last_name>
      <phone>+86-022-88326610</phone>
      <email>412526928@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tianjin Medical University Second Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300211</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Haitao Wang, Ph.D</last_name>
        <phone>+86-022-88326791</phone>
        <email>peterrock2000@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Precision medicine</keyword>
    <keyword>NGS</keyword>
    <keyword>Molecular Tumor Board(MTB)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06030869
  org study id: MyCustom for Solid Tumors
  nct id: NCT06030869
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical
        research project, a genetic biomarker-driven "basket" (tissue-type agonistic) study. The
        target population covers a variety of solid advanced malignant tumors, including but not
        limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck
        squamous carcinoma or lacking effective treatment after standard treatment failure.
  The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical
        research project, a genetic biomarker-driven "basket" (tissue-type agonistic) study. The
        target population covers a variety of solid advanced malignant tumors, including but not
        limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck
        squamous carcinoma or lacking effective treatment after standard treatment failure.The
        overall goal is to develop a more effective research method to test new individualized
        treatment hypotheses.This study will provide comprehensive theoretical and practical support
        for individualized custom model in refractory solid tumors.Archival pathology laboratory
        samples from patients with treatment-refractory advanced solid cancer of any histologic type
        undergo Next Gene Sequencing(NGS) analysis.Fllowing obtain the raw data of the patient's gene
        sequencing, the data are analyzed by the auxiliary decision algorithm to obtain the
        prioritization results of the drugs matched by this patient.The results are subsequently
        reviewed by the Molecular Tumor Board (MTB), where eligible patients can be treated in
        treatment substudies.All patients who receive treatment with a drug available in the protocol
        will be followed for standard efficacy outcomes including clinical efficacy ,clinical safety
        and exploratory endpoints such as biomarkers for drug response, change in the tumor
        microenvironment. For some clinical studies, to meet the primary objective, at least 35% of
        participants had to achieve a PF2S/PFS1 ≥ 1.3 in a sample population of 25 evaluable
        patients. sample size was calculated using an exact single-stage design for phase II studies
        with a one-sided type I error of 5% and a power of 90% under the assumption that PF2S/PFS1≥
        1.3 in ≤10% of patients would be clinically irrelevant, while a success rate ≥ 35% would
        merit further investigation.
  observational model: Cohort
  time perspective: Prospective
  measure: PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)
  time frame: 3 years
  description: The time to progression-free survival during the substudy (PFS2) exceeds the documented time to disease progression-free survival during the last treatment prior to substudy entry (PFS1) by at least 35% (ie, PFS2/PFS1≥1.3) or, if PFS1 is not evaluable, time to progressive disease exceeds 6 months.
  measure: ORR(Objective Response Rate)
  time frame: 3 years
  description: Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
  measure: OS(Overall Survival)
  time frame: 3 years
  description: Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date.
  measure: Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
  time frame: 3 years
  description: Treatment related adverse events with grade 3 or greater severity by CTCAE 5.0.
  measure: Proportion of patients with actionable target
  time frame: 3 years
  description: Number of patients with modifiable genomic variants.
  arm group label: Cohort-A: Patients with actionable targets
  description: In the OncoKB(Precision Oncology Knowledge Base) database, the gene alteration has a variant of clinical evidence in this tumor or other tumor types and is considered to be an interventional variant. Cohort-A may include different observation subgroups. For example, substudy-A1: monotherapy/combination therapy for patients with A1-relative. Substudy-Ax: monotherapy/combination therapy for patients with Ax-relative.
  arm group label: Cohort-B: Patients with potential actionable targets
  description: In cohort-B, the gene alteration that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets. Cohort-B also includes different observation subgroups and clinical trials may conduct in each subgroup. For example, substudy-B1(TP53 as driver gene), substudy-B2(RAS as driver gene), substudy-B3(MAP2K1 as driver gene), substudy-B4(PTEN Loss as driver gene), substudy-B5(11q13 co-amplification as driver genes), Substudy-B6(concomitant actionable alterations), substudy-B7(other driver genes). MTB-guided therapy was defined as having a clinical benefit if the PFS ratio between the longest PFS on MTB-guided therapy and the PFS on the last therapy before MTB-guided therapy was ≥1.3 (i.e., using patients as their own controls) for each substudy. To meet the primary objective, at least 35% of participants had to achieve a PF2S/PFS1 ≥ 1.3 in a sample population of 25 evaluable patients.
  arm group label: Cohort-C: Patients with non-actionable targets
  description: MTB combined with clinical practice and literature reports can not match the gene alteration of targeted therapy, which is considered as an irreversible gene alteration.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Haitao Wang, Ph.D
  role: Principal Investigator
  affiliation: Tianjin Medical University Second Hospital
  last name: Haitao Wang, Ph.D
  phone: +86-022-88326610
  email: peterrock2000@126.com
  last name: Lili Wang, M. Med.
  phone: +86-022-88326610
  email: 412526928@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: Undecided