<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/NCT03784911</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00077264</org_study_id>
    <nct_id>NCT03784911</nct_id>
  </id_info>
  <brief_title>Body Composition During Cancer Treatment</brief_title>
  <acronym>DuringSOZO</acronym>
  <official_title>Assessment of Body Composition During Cancer Treatment Using the SOZO Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prisma Health-Upstate</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ImpediMed Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Prisma Health-Upstate</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>
      The purpose of this study is to assess how bone density and body composition changes over a&#xD;
      cancer patient's treatment via SOZO measurements, DEXA scan (bone density and whole body&#xD;
      composition), performance status tests, food log, urine color test, and other study&#xD;
      assessments. These assessments will begin after cancer diagnosis but prior to intervention,&#xD;
      and continue during treatment and at post-treatment visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, prospective device use study. 50 subjects will be enrolled in the&#xD;
      study. The study will look at the changes in the participants body composition as they go&#xD;
      through cancer treatment using the SOZO device. The SOZO device is intended to estimate the&#xD;
      following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition&#xD;
      (fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular&#xD;
      mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI),&#xD;
      Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during&#xD;
      the course of their cancer treatment where SOZO measurements will be taken as well as other&#xD;
      study measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>SOZO device can detect changes in body composition</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assess change in body composition from baseline to final visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate SOZO with 24-hour food recall.</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assess correlation of SOZO measurements with 24-hour food recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate SOZO with DEXA scan</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate SOZO with standard of care</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assess correlation of SOZO measurements with standard of care measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detect changes in physical performance</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Change from baseline in 6 minute walk test distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate SOZO with urine color test</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assess correlation of SOZO measurements with urine color test.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>During Cancer Treatment Group</arm_group_label>
    <description>Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. Participant will also complete questionnaires and physical assessments during each study visit. These include waist &amp; hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SOZO Device</intervention_name>
    <description>SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes.</description>
    <arm_group_label>During Cancer Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DEXA Scan</intervention_name>
    <description>DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.</description>
    <arm_group_label>During Cancer Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received their first diagnosis of any type of cancer stage I-III. Patients&#xD;
        must have received this diagnosis within 45 days of the Screening/Baseline study visit.&#xD;
        Patients will be ideally enrolled prior to surgical cancer treatment, but enrollment&#xD;
        post-surgery is allowable.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness and ability to provide consent&#xD;
&#xD;
          -  Mentally and physically able to comply with protocol&#xD;
&#xD;
          -  Age 18 and over&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 40 or body weight of &lt;300 pounds&#xD;
&#xD;
          -  Received first cancer diagnosis within 45 days of the Screening/Baseline study visit&#xD;
&#xD;
          -  Diagnosis of cancer stage I-III&#xD;
&#xD;
          -  Attempts to remove the cancer via chemotherapy, immunotherapy, radiation, etc. have&#xD;
             not been initiated. Subjects will ideally enroll prior to any surgical cancer&#xD;
             treatment, but enrollment post-surgery is allowable (capped at 15 subjects)&#xD;
&#xD;
          -  Planned chemotherapy treatment not to exceed 6 months adjuvant treatment. Planned&#xD;
             radiation and/or surgery, as well as planned maintenance therapy is allowable (i.e.&#xD;
             continued treatment with endocrine therapy, monoclonal antibodies, or other&#xD;
             longer-term treatments with minimal side effects) as determined by PI and approved by&#xD;
             sponsor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active implanted medical device (cardiac pacemakers, defibrillators) or connected to&#xD;
             electronic life support devices or patients with other metallic devices that would&#xD;
             interfere with BIS measurements&#xD;
&#xD;
          -  Amputees&#xD;
&#xD;
          -  Any acute swelling condition diagnosed or actively being treated within 30 days of&#xD;
             screening/baseline (including, but not limited to: acute heart failure, renal disease&#xD;
             with dialysis, pulmonary edema, thrombophlebitis, deep vein thrombosis, pleural&#xD;
             effusion, ascites, pregnancy)&#xD;
&#xD;
          -  Patients with basal cell carcinoma or squamous cell skin cancer&#xD;
&#xD;
          -  Currently suffering from uncontrolled intercurrent illness, including: ongoing/active&#xD;
             infection, unstable angina pectoris, or cardiac arrhythmia&#xD;
&#xD;
          -  Enrollment of female breast cancer patients not to exceed 60% of total projected&#xD;
             enrollment. Once this threshold has been reached, these subjects will be excluded&#xD;
&#xD;
          -  Planned orthopedic implant surgery&#xD;
&#xD;
          -  Planned breast implant surgery&#xD;
&#xD;
          -  Presence of or plan for breast expanders post-mastectomy&#xD;
&#xD;
          -  Dependent upon transfusions&#xD;
&#xD;
          -  Any history of organ transplant&#xD;
&#xD;
          -  Presence of colostomy/ostomy&#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>Larry Gluck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prisma Health-Upstate</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Smith, MS</last_name>
    <phone>864-455-5943</phone>
    <email>Marie.Smith5@prismahealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Armand DeSollar, BS</last_name>
    <phone>864-455-6251</phone>
    <email>Armand.Desollar@prismahealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Smith, MS</last_name>
      <phone>864-455-5943</phone>
      <email>Marie.Smith5@prismahealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Churm D, Andrew IM, Holden K, Hildreth AJ, Hawkins C. A questionnaire study of the approach to the anorexia-cachexia syndrome in patients with cancer by staff in a district general hospital. Support Care Cancer. 2009 May;17(5):503-7. doi: 10.1007/s00520-008-0486-1. Epub 2008 Jul 29.</citation>
    <PMID>18663481</PMID>
  </reference>
  <reference>
    <citation>Spiro A, Baldwin C, Patterson A, Thomas J, Andreyev HJ. The views and practice of oncologists towards nutritional support in patients receiving chemotherapy. Br J Cancer. 2006 Aug 21;95(4):431-4. doi: 10.1038/sj.bjc.6603280. Epub 2006 Aug 1.</citation>
    <PMID>16880793</PMID>
  </reference>
  <reference>
    <citation>Pacelli F, Bossola M, Rosa F, Tortorelli AP, Papa V, Doglietto GB. Is malnutrition still a risk factor of postoperative complications in gastric cancer surgery? Clin Nutr. 2008 Jun;27(3):398-407. doi: 10.1016/j.clnu.2008.03.002. Epub 2008 Apr 23.</citation>
    <PMID>18436350</PMID>
  </reference>
  <reference>
    <citation>Bachmann J, Heiligensetzer M, Krakowski-Roosen H, Buchler MW, Friess H, Martignoni ME. Cachexia worsens prognosis in patients with resectable pancreatic cancer. J Gastrointest Surg. 2008 Jul;12(7):1193-201. doi: 10.1007/s11605-008-0505-z. Epub 2008 Mar 18.</citation>
    <PMID>18347879</PMID>
  </reference>
  <reference>
    <citation>Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.</citation>
    <PMID>7424938</PMID>
  </reference>
  <reference>
    <citation>Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.</citation>
    <PMID>16762946</PMID>
  </reference>
  <reference>
    <citation>Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.</citation>
    <PMID>21296615</PMID>
  </reference>
  <reference>
    <citation>Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.</citation>
    <PMID>19342610</PMID>
  </reference>
  <reference>
    <citation>Strassmann G, Fong M, Kenney JS, Jacob CO. Evidence for the involvement of interleukin 6 in experimental cancer cachexia. J Clin Invest. 1992 May;89(5):1681-4. doi: 10.1172/JCI115767.</citation>
    <PMID>1569207</PMID>
  </reference>
  <reference>
    <citation>Falconer JS, Fearon KC, Ross JA, Elton R, Wigmore SJ, Garden OJ, Carter DC. Acute-phase protein response and survival duration of patients with pancreatic cancer. Cancer. 1995 Apr 15;75(8):2077-82. doi: 10.1002/1097-0142(19950415)75:83.0.co;2-9.</citation>
    <PMID>7535184</PMID>
  </reference>
  <reference>
    <citation>Terwee CB, Nieveen Van Dijkum EJ, Gouma DJ, Bakkevold KE, Klinkenbijl JH, Wade TP, van Wagensveld BA, Wong A, van der Meulen JH. Pooling of prognostic studies in cancer of the pancreatic head and periampullary region: the Triple-P study. Triple-P study group. Eur J Surg. 2000 Sep;166(9):706-12. doi: 10.1080/110241500750008466.</citation>
    <PMID>11034467</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Body Composition</keyword>
  <keyword>SOZO</keyword>
  <keyword>Cancer</keyword>
  <keyword>Cancer Treatment</keyword>
  <keyword>Impedimed</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03784911
org study id: Pro00077264
nct id: NCT03784911
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess how bone density and body composition changes over a
      cancer patient's treatment via SOZO measurements, DEXA scan (bone density and whole body
      composition), performance status tests, food log, urine color test, and other study
      assessments. These assessments will begin after cancer diagnosis but prior to intervention,
      and continue during treatment and at post-treatment visits.
This is an observational, prospective device use study. 50 subjects will be enrolled in the
      study. The study will look at the changes in the participants body composition as they go
      through cancer treatment using the SOZO device. The SOZO device is intended to estimate the
      following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition
      (fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular
      mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI),
      Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during
      the course of their cancer treatment where SOZO measurements will be taken as well as other
      study measurements.
observational model: Cohort
time perspective: Prospective
measure: SOZO device can detect changes in body composition
time frame: Up to 6 months
description: Assess change in body composition from baseline to final visit
measure: Correlate SOZO with 24-hour food recall.
time frame: Up to 6 months
description: Assess correlation of SOZO measurements with 24-hour food recall.
measure: Correlate SOZO with DEXA scan
time frame: Up to 6 months
description: Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results
measure: Correlate SOZO with standard of care
time frame: Up to 6 months
description: Assess correlation of SOZO measurements with standard of care measurements
measure: Detect changes in physical performance
time frame: Up to 6 months
description: Change from baseline in 6 minute walk test distance
measure: Correlate SOZO with urine color test
time frame: Up to 6 months
description: Assess correlation of SOZO measurements with urine color test.
arm group label: During Cancer Treatment Group
description: Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. Participant will also complete questionnaires and physical assessments during each study visit. These include waist & hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.
intervention type: Device
intervention name: SOZO Device
description: SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes.
arm group label: During Cancer Treatment Group
intervention type: Device
intervention name: DEXA Scan
description: DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.
arm group label: During Cancer Treatment Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Larry Gluck, MD
role: Principal Investigator
affiliation: Prisma Health-Upstate
last name: Marie Smith, MS
phone: 864-455-5943
email: Marie.Smith5@prismahealth.org
last name: Armand DeSollar, BS
phone: 864-455-6251
email: Armand.Desollar@prismahealth.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Churm D, Andrew IM, Holden K, Hildreth AJ, Hawkins C. A questionnaire study of the approach to the anorexia-cachexia syndrome in patients with cancer by staff in a district general hospital. Support Care Cancer. 2009 May;17(5):503-7. doi: 10.1007/s00520-008-0486-1. Epub 2008 Jul 29.
PMID: 18663481
citation: Spiro A, Baldwin C, Patterson A, Thomas J, Andreyev HJ. The views and practice of oncologists towards nutritional support in patients receiving chemotherapy. Br J Cancer. 2006 Aug 21;95(4):431-4. doi: 10.1038/sj.bjc.6603280. Epub 2006 Aug 1.
PMID: 16880793
citation: Pacelli F, Bossola M, Rosa F, Tortorelli AP, Papa V, Doglietto GB. Is malnutrition still a risk factor of postoperative complications in gastric cancer surgery? Clin Nutr. 2008 Jun;27(3):398-407. doi: 10.1016/j.clnu.2008.03.002. Epub 2008 Apr 23.
PMID: 18436350
citation: Bachmann J, Heiligensetzer M, Krakowski-Roosen H, Buchler MW, Friess H, Martignoni ME. Cachexia worsens prognosis in patients with resectable pancreatic cancer. J Gastrointest Surg. 2008 Jul;12(7):1193-201. doi: 10.1007/s11605-008-0505-z. Epub 2008 Mar 18.
PMID: 18347879
citation: Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.
PMID: 7424938
citation: Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.
PMID: 16762946
citation: Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PMID: 21296615
citation: Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.
PMID: 19342610
citation: Strassmann G, Fong M, Kenney JS, Jacob CO. Evidence for the involvement of interleukin 6 in experimental cancer cachexia. J Clin Invest. 1992 May;89(5):1681-4. doi: 10.1172/JCI115767.
PMID: 1569207
citation: Falconer JS, Fearon KC, Ross JA, Elton R, Wigmore SJ, Garden OJ, Carter DC. Acute-phase protein response and survival duration of patients with pancreatic cancer. Cancer. 1995 Apr 15;75(8):2077-82. doi: 10.1002/1097-0142(19950415)75:83.0.co;2-9.
PMID: 7535184
citation: Terwee CB, Nieveen Van Dijkum EJ, Gouma DJ, Bakkevold KE, Klinkenbijl JH, Wade TP, van Wagensveld BA, Wong A, van der Meulen JH. Pooling of prognostic studies in cancer of the pancreatic head and periampullary region: the Triple-P study. Triple-P study group. Eur J Surg. 2000 Sep;166(9):706-12. doi: 10.1080/110241500750008466.
PMID: 11034467
responsible party type: Sponsor
sharing ipd: No