<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/NCT01668238</url>
  </required_header>
  <id_info>
    <org_study_id>PUCRP201105</org_study_id>
    <nct_id>NCT01668238</nct_id>
  </id_info>
  <brief_title>Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry</brief_title>
  <official_title>Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>XU Zhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this stage of study is to establish discriminant among healthy tissue, benign&#xD;
      and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently,the methods to the diagnosis of tumors include palpation,X-ray,ultrasound,CT and&#xD;
      MRI.The doctors could not get conclusion without a existing mass.The FNB is very popular&#xD;
      nowadays in western countries,but it has been reported that about one-third malignant cases&#xD;
      have been neglected by FNB,for the tissue isn't enough through the needle.There also have&#xD;
      been reports about the increased auxilliary lymphnode metastases for breast cancer because of&#xD;
      FNB.Although the Mammotome has been used widely,it is still traumatic.&#xD;
&#xD;
      Process of malignant transformation of tissues and cells, first proteins, lipids,&#xD;
      carbohydrates and nucleic acids constitute the main substance of tissue and cell structure,&#xD;
      conformation, and the number of occurrence of significant changes in subsequent histological&#xD;
      changes. Fourier transform infrared spectroscopy is the major molecular bond coupling between&#xD;
      the atoms vibrational spectra and molecular rotational spectra.&#xD;
&#xD;
      In this study, consists of three phases:&#xD;
&#xD;
      Stage one:&#xD;
&#xD;
      Continuous enrollment requires inpatient surgery 300 cases of thyroid cancer patients and&#xD;
      breast cancer patients, 200 cases of preoperative determination of tumor on the surface&#xD;
      infrared spectroscopy, infrared spectroscopy of the anterior tumor tissue and lymph node&#xD;
      surgery, measured in vivo; at the same time into the group of 50 patients healthy people, the&#xD;
      determination of surface infrared spectroscopy of the thyroid and breast area. Paraffin&#xD;
      pathological findings as the gold standard, the thyroid and breast cancer patients were&#xD;
      divided into the benign group and malignant group, relatively healthy and good, the&#xD;
      distribution of differences of the surface infrared spectrum of malignant group, while&#xD;
      relatively good in the malignant group IR spectra of the distribution of differences.&#xD;
&#xD;
      Phase II:&#xD;
&#xD;
      Were enrolled, infrared spectroscopy and pathological specimens were collected at different&#xD;
      stages. Paraffin pathological findings as the gold standard, were established two tumor&#xD;
      surface, the infrared spectra of the fresh in vitro and in vivo for tumor benign or malignant&#xD;
      diagnosis discrimination system.&#xD;
&#xD;
      Phase III:&#xD;
&#xD;
      Into the infrared spectra collected data on behalf of the above-mentioned discrimination&#xD;
      system to verify its sensitivity, specificity and accuracy; both paraffin pathological&#xD;
      findings as the gold standard to compare the infrared spectral discrimination systems and&#xD;
      intraoperative frozen section pathology for the diagnosis of benign and malignant tumors&#xD;
      correctly rate differences, to explore the clinical value of infrared spectroscopy&#xD;
      discrimination system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">September 2012</completion_date>
  <primary_completion_date type="Anticipated">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pathologic findings</measure>
    <time_frame>12 months</time_frame>
    <description>In operation patients, discriminant between benign and malignant thyroid and breast tumors are established by fourier transform infrared spectrometry variables, and pathologic diagnoses are gold standard.&#xD;
Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Thyroid Tumor</condition>
  <condition>Breast Tumor</condition>
  <arm_group>
    <arm_group_label>malignant tumor</arm_group_label>
    <description>Inpatients with malignant tumors of thyroid and breast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>benign tumor</arm_group_label>
    <description>Inpatients with benign tumors of thyroid and breast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Volunteers without thyroid or breast tumors</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. Hospitalized patients undergoing thyroid and breast tumor sugery;&#xD;
&#xD;
          2. Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients:&#xD;
&#xD;
          1. Inclusion Criteria:&#xD;
&#xD;
               -  Patients undergoing thyroid and breast tumor surgery.&#xD;
&#xD;
               -  Informed consent form is signed.&#xD;
&#xD;
               -  An optical fibre and ATR probe can be applied to the operation field in process&#xD;
                  of open or laparoscopic surgery.&#xD;
&#xD;
               -  Male or female between the age of 18 to 80.&#xD;
&#xD;
               -  Patients can tolerate surgery and with non of these diseases: severe heart&#xD;
                  failure, liver failure, renal failure or respiratory failure.&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               -  A state of emergency, such as Gastrointestinal bleeding, perforation, or acute&#xD;
                  obstruction.&#xD;
&#xD;
               -  unstable situation in operation, such as anesthetic accidents or intraoperative&#xD;
                  cerebral vascular accident.&#xD;
&#xD;
               -  From investigators' perspective patients do not suitable for the study&#xD;
&#xD;
        Healthy volunteers' inclusion criteria:&#xD;
&#xD;
          -  Informed consent form is signed.&#xD;
&#xD;
          -  No thyroid or breast cancer according to the professional judgment of general surgeon.&#xD;
&#xD;
          -  No thyroid or breast disease according to thyroid function tests and breast type&#xD;
             B-ultrasonic test within 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhi Xu, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhi XU, PHD MD</last_name>
    <phone>86-10-82267331</phone>
    <email>xuzhi123456@sohu.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Long Cui</last_name>
    <phone>86-10-82267328</phone>
    <email>cuilong1978@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhi XU, PhD MD</last_name>
      <phone>86-10-82267331</phone>
      <email>xuzhi123456@sohu.com</email>
    </contact>
    <contact_backup>
      <last_name>Long Cui</last_name>
      <phone>82267328</phone>
      <email>cuilong1978@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>XU Zhi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Thyroid tumor</keyword>
  <keyword>Breast tumor</keyword>
  <keyword>Fourier Transform Infrared Spectrometry</keyword>
  <keyword>Tumor Diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT01668238
org study id: PUCRP201105
nct id: NCT01668238
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this stage of study is to establish discriminant among healthy tissue, benign
      and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.
Recently,the methods to the diagnosis of tumors include palpation,X-ray,ultrasound,CT and
      MRI.The doctors could not get conclusion without a existing mass.The FNB is very popular
      nowadays in western countries,but it has been reported that about one-third malignant cases
      have been neglected by FNB,for the tissue isn't enough through the needle.There also have
      been reports about the increased auxilliary lymphnode metastases for breast cancer because of
      FNB.Although the Mammotome has been used widely,it is still traumatic.

      Process of malignant transformation of tissues and cells, first proteins, lipids,
      carbohydrates and nucleic acids constitute the main substance of tissue and cell structure,
      conformation, and the number of occurrence of significant changes in subsequent histological
      changes. Fourier transform infrared spectroscopy is the major molecular bond coupling between
      the atoms vibrational spectra and molecular rotational spectra.

      In this study, consists of three phases:

      Stage one:

      Continuous enrollment requires inpatient surgery 300 cases of thyroid cancer patients and
      breast cancer patients, 200 cases of preoperative determination of tumor on the surface
      infrared spectroscopy, infrared spectroscopy of the anterior tumor tissue and lymph node
      surgery, measured in vivo; at the same time into the group of 50 patients healthy people, the
      determination of surface infrared spectroscopy of the thyroid and breast area. Paraffin
      pathological findings as the gold standard, the thyroid and breast cancer patients were
      divided into the benign group and malignant group, relatively healthy and good, the
      distribution of differences of the surface infrared spectrum of malignant group, while
      relatively good in the malignant group IR spectra of the distribution of differences.

      Phase II:

      Were enrolled, infrared spectroscopy and pathological specimens were collected at different
      stages. Paraffin pathological findings as the gold standard, were established two tumor
      surface, the infrared spectra of the fresh in vitro and in vivo for tumor benign or malignant
      diagnosis discrimination system.

      Phase III:

      Into the infrared spectra collected data on behalf of the above-mentioned discrimination
      system to verify its sensitivity, specificity and accuracy; both paraffin pathological
      findings as the gold standard to compare the infrared spectral discrimination systems and
      intraoperative frozen section pathology for the diagnosis of benign and malignant tumors
      correctly rate differences, to explore the clinical value of infrared spectroscopy
      discrimination system.
time perspective: Cross-Sectional
measure: pathologic findings
time frame: 12 months
description: In operation patients, discriminant between benign and malignant thyroid and breast tumors are established by fourier transform infrared spectrometry variables, and pathologic diagnoses are gold standard.
Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.
arm group label: malignant tumor
description: Inpatients with malignant tumors of thyroid and breast
arm group label: benign tumor
description: Inpatients with benign tumors of thyroid and breast
arm group label: Healthy volunteers
description: Volunteers without thyroid or breast tumors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhi Xu, PhD MD
role: Principal Investigator
affiliation: Peking University Third Hospital
last name: Zhi XU, PHD MD
phone: 86-10-82267331
email: xuzhi123456@sohu.com
last name: Long Cui
phone: 86-10-82267328
email: cuilong1978@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University
investigator full name: XU Zhi
investigator title: Professor
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases