<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/NCT03261752</url>
  </required_header>
  <id_info>
    <org_study_id>CRC</org_study_id>
    <nct_id>NCT03261752</nct_id>
  </id_info>
  <brief_title>New Genes in the Carcinogenesis of Colorectal Cancer</brief_title>
  <official_title>Investigating the Role of SPG20,STK31 Genes in the Carcinogenesis of Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an&#xD;
      estimated 1.3 million new cases and &gt;500,000 mortality ⁄ year . is the fourth leading cause&#xD;
      of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the&#xD;
      worldwide&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      colo rectal cancer represents a global and local problem, as it is one of the commonest types&#xD;
      of cancer all over the world. Globally, Colo rectal cancer in women (9.2% of diagnoses) it is&#xD;
      the second most common cause of cancer . it is the third most common in men (10.0%). After&#xD;
      lung, stomach, and liver cancer it is the fourth most common cause of cancer death.&#xD;
&#xD;
      Cancer is a multistep procedure resulting from an ongoing accretion of genetic and epigenetic&#xD;
      fluctuations to the genome.&#xD;
&#xD;
      Spartin is a protein that in humans is encoded by the SPG20 gene. This protein may be&#xD;
      involved in endosomal trafficking, microtubule dynamics, or both functions. Aberrant promoter&#xD;
      methylation of genes is a common epigenetic alteration in colo rectal cancer .&#xD;
&#xD;
      This has stimulated the prospect to implement a dependable, reasonable and simple approach&#xD;
      for Colo rectal detection . The SPG20 gene is situated in chromosome band 13q13.3; the SPG20&#xD;
      gene converts the spartin protein, which is a multi functional protein that has formerly been&#xD;
      recognized to be complicated in intra cellular epidermal growth factor receptor trading , The&#xD;
      serine-threonine kinase 31 (STK31) gene was initially identified through cDNA subtraction as&#xD;
      a testis-specific protein kinase gene expressed in mouse spermatogonia . Recently, STK31 has&#xD;
      been described as a novel cancer testis (CT) antigen, highly expressed in Gastrointestinal&#xD;
      cancer cells (colo rectal, gastric and esophageal cancer), while restricted to testis and&#xD;
      fetal brain in normal tissues .&#xD;
&#xD;
      It was found that SPG20 is mutated in Troy er syndrome, an hereditary spastic paraplegia&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>detection of SPG20&amp;STK31 genes</measure>
    <time_frame>5 months</time_frame>
    <description>detection of SPG20&amp;STK31 genes and prediction future treatment for colo-rectal cancer</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Colo-rectal Cancer</condition>
  <arm_group>
    <arm_group_label>patient with cancer</arm_group_label>
    <description>blood sample will be collected from patient before and after treatment (surgery or chemotherapy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy people</arm_group_label>
    <description>blood sample will be collected for comparison</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <description>Total genomic DNA will be extracted DNA extraction kit using a QIAamp DNA Blood Mini kit .Genetic analysis of both SPG20 &amp;STK31 by RTPCR.</description>
    <arm_group_label>healthy people</arm_group_label>
    <arm_group_label>patient with cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient between 35-65 who are newly diagnosed with colorectal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 35-65&#xD;
&#xD;
          -  patient with colorectal cancer (at any stage)&#xD;
&#xD;
          -  both sex included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pediatric patients&#xD;
&#xD;
          -  patient with insufficient data&#xD;
&#xD;
          -  cardiac patient&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>mariana anwar, M.st</last_name>
    <phone>01012944965</phone>
    <email>mariana.10@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naglaa Idriss</last_name>
    <phone>01003830234</phone>
    <email>naglaaidriss@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mariana Anwar</investigator_full_name>
    <investigator_title>Demonstrator of cancer biology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinogenesis</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/NCT03261752
org study id: CRC
nct id: NCT03261752
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an
      estimated 1.3 million new cases and >500,000 mortality ⁄ year . is the fourth leading cause
      of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the
      worldwide
colo rectal cancer represents a global and local problem, as it is one of the commonest types
      of cancer all over the world. Globally, Colo rectal cancer in women (9.2% of diagnoses) it is
      the second most common cause of cancer . it is the third most common in men (10.0%). After
      lung, stomach, and liver cancer it is the fourth most common cause of cancer death.

      Cancer is a multistep procedure resulting from an ongoing accretion of genetic and epigenetic
      fluctuations to the genome.

      Spartin is a protein that in humans is encoded by the SPG20 gene. This protein may be
      involved in endosomal trafficking, microtubule dynamics, or both functions. Aberrant promoter
      methylation of genes is a common epigenetic alteration in colo rectal cancer .

      This has stimulated the prospect to implement a dependable, reasonable and simple approach
      for Colo rectal detection . The SPG20 gene is situated in chromosome band 13q13.3; the SPG20
      gene converts the spartin protein, which is a multi functional protein that has formerly been
      recognized to be complicated in intra cellular epidermal growth factor receptor trading , The
      serine-threonine kinase 31 (STK31) gene was initially identified through cDNA subtraction as
      a testis-specific protein kinase gene expressed in mouse spermatogonia . Recently, STK31 has
      been described as a novel cancer testis (CT) antigen, highly expressed in Gastrointestinal
      cancer cells (colo rectal, gastric and esophageal cancer), while restricted to testis and
      fetal brain in normal tissues .

      It was found that SPG20 is mutated in Troy er syndrome, an hereditary spastic paraplegia
observational model: Case-Control
time perspective: Prospective
measure: detection of SPG20&STK31 genes
time frame: 5 months
description: detection of SPG20&STK31 genes and prediction future treatment for colo-rectal cancer
arm group label: patient with cancer
description: blood sample will be collected from patient before and after treatment (surgery or chemotherapy)
arm group label: healthy people
description: blood sample will be collected for comparison
intervention type: Diagnostic Test
intervention name: blood sample
description: Total genomic DNA will be extracted DNA extraction kit using a QIAamp DNA Blood Mini kit .Genetic analysis of both SPG20 &STK31 by RTPCR.
arm group label: healthy people
arm group label: patient with cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mariana anwar, M.st
phone: 01012944965
email: mariana.10@yahoo.com
last name: Naglaa Idriss
phone: 01003830234
email: naglaaidriss@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mariana Anwar
investigator title: Demonstrator of cancer biology
mesh term: Carcinogenesis