<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/NCT04411290</url>
  </required_header>
  <id_info>
    <org_study_id>B.10.1.TKH.4.34.H.GP.0.01/172</org_study_id>
    <nct_id>NCT04411290</nct_id>
  </id_info>
  <brief_title>Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases</brief_title>
  <official_title>Correlation of Malignancy Predictors, Bethesda (I-VI) and TI-RADS Scores (I-V) With Final Histopathology in Patients Undergoing Total Thyroidectomy 34 Years After Chernobyl Disaster: Multi-centric Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 the last decades, thyroid cancer incidence has continuously increased all over the world,&#xD;
      almost exclusively due to a sharp rise in the incidence of the papillary histologic subtype,&#xD;
      which has the highest incidence of multifocality. Furthermore, Black Sea and Eastern European&#xD;
      regions are both endemic and known to have been under the influence of Chernobyl nuclear&#xD;
      explosion. Although overscreening might have a role in certain parts of the world, the&#xD;
      predictors of malignancy such as family history, genetical disorders, previous radiation&#xD;
      exposure, low iodine intake, diabetes and obesity, should also be taken into consideration in&#xD;
      determining the extent of surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High-frequency ultrasound (US) is increasingly used to help distinguish malignancy in&#xD;
      patients with solitary or multiple nodules, and US-guided fine needle aspiration (FNA) has&#xD;
      become the gold standard test for detecting thyroid cancer. Moreover, a further US-based risk&#xD;
      stratification of thyroid nodules with Thyroid Imaging Reporting and Data System (TI-RADS)&#xD;
      has been currently proposed for better and easier decision making. However, the presence of&#xD;
      multiple nodules in the thyroid gland may decrease the diagnostic value of these preoperative&#xD;
      diagnostic tools. The prevalence of incidental carcinoma identified on the final histological&#xD;
      examination of the patients who underwent surgery for presumably benign thyroid diseases was&#xD;
      previously reported to be roughly around 5 to 10%. Most of the previous studies also showed a&#xD;
      lower risk of carcinoma in multinodular goitre (MNG) compared to solitary thyroid nodule&#xD;
      (STN). However, some recent surgical series have reported that the risk of thyroid carcinoma&#xD;
      in benign thyroid diseases is significantly higher than previously reported.&#xD;
&#xD;
      The purpose of the present study is to detect the accuracy of preoperative cytology and&#xD;
      US-findings (TI-RADS) and the prevalence of thyroid carcinoma in patients operated for&#xD;
      thyroid diseases and to discuss all malignancy risk factors in detail along with final&#xD;
      histopathological report. Cytology-histology discrepant cases will also be further evaluated&#xD;
      for sampling and interpretation errors, and possible solutions to increase the accuracy of&#xD;
      preop testing are going to be proposed. The accuracy of the preference of total thyroidectomy&#xD;
      procedure will be evaluated considering the prevalence of incidental carcinomas diagnosed&#xD;
      postoperatively, and whether there are variations in the risk of malignancy with respect to&#xD;
      final pathology of patients will also be discussed in detail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Preoperative Evaluation of Malignancy Risk Factors-How many risk factors are present?</measure>
    <time_frame>12 months</time_frame>
    <description>Malignancy risk factors: 1. Demographics (Age and gender-Male/Female), 2. Smoking history (Yes/No, duration and number/day), 3. Iodine-deficient diet (Yes/No), 4. Born at an endemic area (Yes/No), 5. Presence in an endemic area (Yes/No), 6. Radiation exposure (Yes/No), 7. Radiation treatment during childhood (Yes/No), 8. Head and neck carcinoma (Yes/No), 9. Other carcinoma history (Yes/No, if yes specify.........) 10. Family history of thyroid disease (Yes/No), 11. Family history of other carcinomas (Yes/No), 12. Personal history of thyroid carcinoma/surgery (Yes/No, if yes, pathology……..), 13. Personal history of other carcinomas (e.g. colonic polyps? breast disease?......) 14. Genetic disorders (Yes/No), 15. Obesity (Body mass index - ? kg/m2), 16. Diabetes mellitus (Yes/No) should be evaluated for each patient before surgery- The number of risk factors will be compared with malignancy rate found at final histopathology report.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preoperative Bethesda category, Fine needle aspiration (FNA) cytology report</measure>
    <time_frame>12 months</time_frame>
    <description>Bethesda score-FNA cytology report- as I, II, III, IV, V or VI. Cytology report will be compared with final histology report for each patient for malşgnancy rate and multifocality I. Nondiagnostic or unsatisfactory, II. Benign, III. Atypia of undetermined significance (AUS) or follicular lesion of undetermined significance (FLUS), IV. Follicular neoplasm or suspicious for a follicular neoplasm-Preoperative cytology category will be compared with postoperative final histopathology report for malignancy rate, multifocality and cases with cytology-histopathology discrepancy will be evaluated further for biopsy techniques and cytology mis-interpretations.&#xD;
V. Suspicious for malignancy, VI. Malignant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preoperative ultrasound evaluation with Thyroid Imaging Reporting and Data System (TI-RADS)</measure>
    <time_frame>12 months</time_frame>
    <description>TI-RADS score-Ultrasound evaluation of thyroid nodues- as I, II, III, IV or V. TI-RADS scores will be compared with final histopathology report to see malignancy rates and accuracy of TI-RADS.&#xD;
TI-RADS 1: Normal thyroid gland. No focal lesion. TI-RADS 2: Benign nodules. Noticeably benign pattern (0% risk of malignancy) TI-RADS 3: Probably benign nodules (&lt;5% risk of malignancy)&#xD;
TI-RADS 4:&#xD;
4a - Undetermined nodules (5-10% risk of malignancy) Score of 1.&#xD;
4b - Suspicious nodules (10-50% risk of malignancy) Score of 2.&#xD;
4c - Highly suspicious nodules (50-85% risk of malignancy) Score of 3-4 TI-RADS 5: Probably malignant nodules (&gt;85% risk of malignancy) Score of 5 or higher TI-RADS 6: Biopsy-proven malignancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total thyroidectomy for both benign and malign thyroid diseases</measure>
    <time_frame>12 months</time_frame>
    <description>Final histopathology report-After surgery (all patients should have a final histopathology report after total thyroidectomy operation). Final histology report will be correlated to Malignancy risk factors (number), Bethesda category (accuracy, false negativity/positivity) and TI-RADS (accuracy, false negativity/positivity)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Thyroid Carcinoma</condition>
  <condition>Thyroid Papillary Carcinoma</condition>
  <condition>Multinodular Goiter, Adolescent</condition>
  <condition>Solitary Thyroid Nodule</condition>
  <condition>Thyroid Diseases</condition>
  <condition>Multifocal Dysplasia</condition>
  <condition>Aspiration</condition>
  <condition>Thyroid Nodule</condition>
  <condition>Thyroid Cancer, Papillary</condition>
  <condition>Thyroid Neoplasms</condition>
  <condition>Thyroid Goiter</condition>
  <arm_group>
    <arm_group_label>Total Thyroidectomy (TT)-indicated patients</arm_group_label>
    <description>Patients with presumably benign thyroid disease (multinodular goitre, solitary thyroid nodule, toxic goitre, etc.) Patients with thyroid carcinoma (biopsy-proved) Total thyroidectomy preference by the primary surgeon</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total thyroidectomy (TT)</intervention_name>
    <description>Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)</description>
    <arm_group_label>Total Thyroidectomy (TT)-indicated patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with benign or malign thyroid disease, eligable for total thyroidectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;17 years all patients with benign/malign thyroid disease, total thyroidectomy is&#xD;
             indicated/preferred by both primary surgeon and patient (signed informed consent is a&#xD;
             must)&#xD;
&#xD;
          -  All patients should have a malignancy predictive factors forms filled in&#xD;
&#xD;
          -  All patients should have fine needle aspiration cytology (Bethesda category) available&#xD;
&#xD;
          -  All patients should have an ultrasound evaluated according to TI-RADS&#xD;
&#xD;
          -  All patients should have a final histopathology report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are prepared for thyroid surgery other than total thyroidectomy procedure&#xD;
&#xD;
          -  Age&lt;17 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ethem UNAL, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assoc. Professor of General Surgery and Surgical Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sema YUKSEKDAG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instructor in General Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Umraniye Education and Research Hospital, Health Sciences Universit</name>
      <address>
        <city>Istanbul</city>
        <zip>34764</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Delfim RLC, Veiga LCGD, Vidal APA, Lopes FPPL, Vaisman M, Teixeira PFDS. Likelihood of malignancy in thyroid nodules according to a proposed Thyroid Imaging Reporting and Data System (TI-RADS) classification merging suspicious and benign ultrasound features. Arch Endocrinol Metab. 2017 May-Jun;61(3):211-221. doi: 10.1590/2359-3997000000262. Epub 2017 Mar 27.</citation>
    <PMID>28699990</PMID>
  </results_reference>
  <results_reference>
    <citation>Tufano RP, Noureldine SI, Angelos P. Incidental thyroid nodules and thyroid cancer: considerations before determining management. JAMA Otolaryngol Head Neck Surg. 2015 Jun;141(6):566-72. doi: 10.1001/jamaoto.2015.0647.</citation>
    <PMID>25928353</PMID>
  </results_reference>
  <results_reference>
    <citation>Tan H, Li Z, Li N, Qian J, Fan F, Zhong H, Feng J, Xu H, Li Z. Thyroid imaging reporting and data system combined with Bethesda classification in qualitative thyroid nodule diagnosis. Medicine (Baltimore). 2019 Dec;98(50):e18320. doi: 10.1097/MD.0000000000018320.</citation>
    <PMID>31852120</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ethem Unal, M.D., PhD, Associate Prof of Surgery &amp; Surgic</investigator_full_name>
    <investigator_title>Assoc. Professor of General Surgery and Surgical Oncology</investigator_title>
  </responsible_party>
  <keyword>Total Thyroidectomy</keyword>
  <keyword>Black Sea</keyword>
  <keyword>Eastern Europe</keyword>
  <keyword>Radiation</keyword>
  <keyword>Endemic</keyword>
  <keyword>Fine needle aspiration (FNA)</keyword>
  <keyword>Multifocality</keyword>
  <keyword>Bethesda</keyword>
  <keyword>Cytology</keyword>
  <keyword>Thyroid Imaging Reporting and Data System (TI-RADS)</keyword>
  <keyword>International</keyword>
  <keyword>Multi-centric</keyword>
  <keyword>Multicentric study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Carcinoma, Papillary</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Goiter</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Excel documents will be available (Patient initials and medical record numbers shaded XX). Demographics, BMI, malignancy risk factors, Bethesda and TI-RADS scores and final histopathology reports</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>June 01, 2020</ipd_time_frame>
    <ipd_access_criteria>Contact for all available forms by email Open to all centers (especially for Black Sea and Estern European centers, but not limited to)</ipd_access_criteria>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Principal investigator data</doc_type>
      <doc_url>https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&amp;hl=tr</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04411290
org study id: B.10.1.TKH.4.34.H.GP.0.01/172
nct id: NCT04411290
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the last decades, thyroid cancer incidence has continuously increased all over the world,
      almost exclusively due to a sharp rise in the incidence of the papillary histologic subtype,
      which has the highest incidence of multifocality. Furthermore, Black Sea and Eastern European
      regions are both endemic and known to have been under the influence of Chernobyl nuclear
      explosion. Although overscreening might have a role in certain parts of the world, the
      predictors of malignancy such as family history, genetical disorders, previous radiation
      exposure, low iodine intake, diabetes and obesity, should also be taken into consideration in
      determining the extent of surgery.
High-frequency ultrasound (US) is increasingly used to help distinguish malignancy in
      patients with solitary or multiple nodules, and US-guided fine needle aspiration (FNA) has
      become the gold standard test for detecting thyroid cancer. Moreover, a further US-based risk
      stratification of thyroid nodules with Thyroid Imaging Reporting and Data System (TI-RADS)
      has been currently proposed for better and easier decision making. However, the presence of
      multiple nodules in the thyroid gland may decrease the diagnostic value of these preoperative
      diagnostic tools. The prevalence of incidental carcinoma identified on the final histological
      examination of the patients who underwent surgery for presumably benign thyroid diseases was
      previously reported to be roughly around 5 to 10%. Most of the previous studies also showed a
      lower risk of carcinoma in multinodular goitre (MNG) compared to solitary thyroid nodule
      (STN). However, some recent surgical series have reported that the risk of thyroid carcinoma
      in benign thyroid diseases is significantly higher than previously reported.

      The purpose of the present study is to detect the accuracy of preoperative cytology and
      US-findings (TI-RADS) and the prevalence of thyroid carcinoma in patients operated for
      thyroid diseases and to discuss all malignancy risk factors in detail along with final
      histopathological report. Cytology-histology discrepant cases will also be further evaluated
      for sampling and interpretation errors, and possible solutions to increase the accuracy of
      preop testing are going to be proposed. The accuracy of the preference of total thyroidectomy
      procedure will be evaluated considering the prevalence of incidental carcinomas diagnosed
      postoperatively, and whether there are variations in the risk of malignancy with respect to
      final pathology of patients will also be discussed in detail.
observational model: Cohort
time perspective: Prospective
measure: Preoperative Evaluation of Malignancy Risk Factors-How many risk factors are present?
time frame: 12 months
description: Malignancy risk factors: 1. Demographics (Age and gender-Male/Female), 2. Smoking history (Yes/No, duration and number/day), 3. Iodine-deficient diet (Yes/No), 4. Born at an endemic area (Yes/No), 5. Presence in an endemic area (Yes/No), 6. Radiation exposure (Yes/No), 7. Radiation treatment during childhood (Yes/No), 8. Head and neck carcinoma (Yes/No), 9. Other carcinoma history (Yes/No, if yes specify.........) 10. Family history of thyroid disease (Yes/No), 11. Family history of other carcinomas (Yes/No), 12. Personal history of thyroid carcinoma/surgery (Yes/No, if yes, pathology……..), 13. Personal history of other carcinomas (e.g. colonic polyps? breast disease?......) 14. Genetic disorders (Yes/No), 15. Obesity (Body mass index - ? kg/m2), 16. Diabetes mellitus (Yes/No) should be evaluated for each patient before surgery- The number of risk factors will be compared with malignancy rate found at final histopathology report.
measure: Preoperative Bethesda category, Fine needle aspiration (FNA) cytology report
time frame: 12 months
description: Bethesda score-FNA cytology report- as I, II, III, IV, V or VI. Cytology report will be compared with final histology report for each patient for malşgnancy rate and multifocality I. Nondiagnostic or unsatisfactory, II. Benign, III. Atypia of undetermined significance (AUS) or follicular lesion of undetermined significance (FLUS), IV. Follicular neoplasm or suspicious for a follicular neoplasm-Preoperative cytology category will be compared with postoperative final histopathology report for malignancy rate, multifocality and cases with cytology-histopathology discrepancy will be evaluated further for biopsy techniques and cytology mis-interpretations.
V. Suspicious for malignancy, VI. Malignant.
measure: Preoperative ultrasound evaluation with Thyroid Imaging Reporting and Data System (TI-RADS)
time frame: 12 months
description: TI-RADS score-Ultrasound evaluation of thyroid nodues- as I, II, III, IV or V. TI-RADS scores will be compared with final histopathology report to see malignancy rates and accuracy of TI-RADS.
TI-RADS 1: Normal thyroid gland. No focal lesion. TI-RADS 2: Benign nodules. Noticeably benign pattern (0% risk of malignancy) TI-RADS 3: Probably benign nodules (<5% risk of malignancy)
TI-RADS 4:
4a - Undetermined nodules (5-10% risk of malignancy) Score of 1.
4b - Suspicious nodules (10-50% risk of malignancy) Score of 2.
4c - Highly suspicious nodules (50-85% risk of malignancy) Score of 3-4 TI-RADS 5: Probably malignant nodules (>85% risk of malignancy) Score of 5 or higher TI-RADS 6: Biopsy-proven malignancy
measure: Total thyroidectomy for both benign and malign thyroid diseases
time frame: 12 months
description: Final histopathology report-After surgery (all patients should have a final histopathology report after total thyroidectomy operation). Final histology report will be correlated to Malignancy risk factors (number), Bethesda category (accuracy, false negativity/positivity) and TI-RADS (accuracy, false negativity/positivity)
arm group label: Total Thyroidectomy (TT)-indicated patients
description: Patients with presumably benign thyroid disease (multinodular goitre, solitary thyroid nodule, toxic goitre, etc.) Patients with thyroid carcinoma (biopsy-proved) Total thyroidectomy preference by the primary surgeon
intervention type: Procedure
intervention name: Total thyroidectomy (TT)
description: Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)
arm group label: Total Thyroidectomy (TT)-indicated patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Ethem UNAL, MD, PhD
role: Study Chair
affiliation: Assoc. Professor of General Surgery and Surgical Oncology
last name: Sema YUKSEKDAG, MD
role: Principal Investigator
affiliation: Instructor in General Surgery
facility: 
country: Turkey
citation: Delfim RLC, Veiga LCGD, Vidal APA, Lopes FPPL, Vaisman M, Teixeira PFDS. Likelihood of malignancy in thyroid nodules according to a proposed Thyroid Imaging Reporting and Data System (TI-RADS) classification merging suspicious and benign ultrasound features. Arch Endocrinol Metab. 2017 May-Jun;61(3):211-221. doi: 10.1590/2359-3997000000262. Epub 2017 Mar 27.
PMID: 28699990
citation: Tufano RP, Noureldine SI, Angelos P. Incidental thyroid nodules and thyroid cancer: considerations before determining management. JAMA Otolaryngol Head Neck Surg. 2015 Jun;141(6):566-72. doi: 10.1001/jamaoto.2015.0647.
PMID: 25928353
citation: Tan H, Li Z, Li N, Qian J, Fan F, Zhong H, Feng J, Xu H, Li Z. Thyroid imaging reporting and data system combined with Bethesda classification in qualitative thyroid nodule diagnosis. Medicine (Baltimore). 2019 Dec;98(50):e18320. doi: 10.1097/MD.0000000000018320.
PMID: 31852120
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
investigator title: Assoc. Professor of General Surgery and Surgical Oncology
mesh term: Carcinoma
mesh term: Thyroid Neoplasms
mesh term: Thyroid Nodule
mesh term: Carcinoma, Papillary
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases
mesh term: Goiter
sharing ipd: Yes
ipd description: All Excel documents will be available (Patient initials and medical record numbers shaded XX). Demographics, BMI, malignancy risk factors, Bethesda and TI-RADS scores and final histopathology reports
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: June 01, 2020
ipd access criteria: Contact for all available forms by email Open to all centers (especially for Black Sea and Estern European centers, but not limited to)
study doc: 