<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/NCT03028519</url>
  </required_header>
  <id_info>
    <org_study_id>7488</org_study_id>
    <nct_id>NCT03028519</nct_id>
  </id_info>
  <brief_title>Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer</brief_title>
  <official_title>Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of&#xD;
      diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D&#xD;
      receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D&#xD;
      repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in&#xD;
      these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will contain 2 cohorts: those with normal serum 25(OH)D and those with low serum&#xD;
      25(OH)D at enrollment. The study will take place in women with ovarian, primary peritoneal,&#xD;
      and fallopian tube cancer.&#xD;
&#xD;
      Patients who have given written consent to enroll in the study will have a serum 25(OH)D&#xD;
      levels, serum leptin levels, and vitamin D receptor FokI single nucleotide polymorphism&#xD;
      analyzed at the time of diagnosis. Patients with vitamin D deficiency will be prescribed&#xD;
      vitamin D supplementation according to current guidelines. Treatment with cholecalciferol&#xD;
      will not impact cancer therapy. Participants treatment course information will be collected&#xD;
      prospectively, but will not be dictated by this study. Serum 25(OH)D and leptin levels will&#xD;
      be collected again at the completion of primary therapy, 6 months after the completion of&#xD;
      primary therapy, and at the time of disease recurrence. If patients remain vitamin D&#xD;
      deficient at any of these follow-up time points, they will be referred to an endocrinologist&#xD;
      for further work-up and treatment of their vitamin D deficiency. Data collection will&#xD;
      continue for up to 1 year after enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Related Morbidity</measure>
    <time_frame>1 year</time_frame>
    <description>Chemotherapy and 30-day post-operative surgical morbidity will be measured and reported in aggregate as number of patients with chemotherapy-related and/or surgery-related morbidity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>1 year</time_frame>
    <description>disease free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify serum 25(OH)D and serum leptin relationship</measure>
    <time_frame>baseline, at completion of primary cancer therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy</time_frame>
    <description>Change in serum 25(OH)D levels with vitamin D repletion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate serum level changes</measure>
    <time_frame>baseline, at completion of primary therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy]</time_frame>
    <description>Change in serum Leptin levels with vitamin D repletion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mutation Status</measure>
    <time_frame>at time of enrollment</time_frame>
    <description>Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin D levels will be measured at the time of routine blood work. If Vitamin D levels are found to be low, patients will take 50,000 IU of vitamin D3 weekly daily as maintenance therapy. There is no prospective control arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Vitamin D3</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a histologic diagnosis of ovarian, fallopian tube, or primary&#xD;
             peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional&#xD;
             radiology, paracentesis, or CT guided core biopsy. Histologic documentation of the&#xD;
             original primary tumor is required via the pathology report.&#xD;
&#xD;
          -  Patients must have adequate: Renal function: Glomerular Filtration Rate (GFR) &gt; 30;&#xD;
             Gastrointestinal absorption: No underlying malabsorption syndrome (i.e. inflammatory&#xD;
             bowel disease, celiac disease)&#xD;
&#xD;
          -  Ability to tolerate oral medication&#xD;
&#xD;
          -  Patients taking vitamin D at the time of enrollment without a diagnosis of vitamin D&#xD;
             deficiency&#xD;
&#xD;
          -  Patients of childbearing potential must have a negative pregnancy test prior to the&#xD;
             study entry and be practicing an effective form of contraception.&#xD;
&#xD;
          -  If applicable, patients must discontinue breastfeeding prior to study entry.&#xD;
&#xD;
          -  Patients must be at least 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known pre-existing diagnosis of vitamin D deficiency.&#xD;
&#xD;
          -  Patients with renal disease and a GFR &lt;30&#xD;
&#xD;
          -  Patients with primary hyperparathyroidism&#xD;
&#xD;
          -  Patients with other invasive malignancies, with the exception of nonmelanoma skin&#xD;
             cancer.&#xD;
&#xD;
          -  Patients with concomitant endometrial cancer diagnosed at the time of their ovarian&#xD;
             cancer are allowed to participate if the endometrial cancer is International&#xD;
             Federation of Gynecology and Obstetrics stage 1B or less.&#xD;
&#xD;
          -  Patients of childbearing potential, not practicing adequate contraception, patients&#xD;
             who are pregnant, or patients who are breastfeeding are not eligible for this trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Holman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03028519/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03028519/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03028519
org study id: 7488
nct id: NCT03028519
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of
      diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D
      receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D
      repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in
      these patients.
This study will contain 2 cohorts: those with normal serum 25(OH)D and those with low serum
      25(OH)D at enrollment. The study will take place in women with ovarian, primary peritoneal,
      and fallopian tube cancer.

      Patients who have given written consent to enroll in the study will have a serum 25(OH)D
      levels, serum leptin levels, and vitamin D receptor FokI single nucleotide polymorphism
      analyzed at the time of diagnosis. Patients with vitamin D deficiency will be prescribed
      vitamin D supplementation according to current guidelines. Treatment with cholecalciferol
      will not impact cancer therapy. Participants treatment course information will be collected
      prospectively, but will not be dictated by this study. Serum 25(OH)D and leptin levels will
      be collected again at the completion of primary therapy, 6 months after the completion of
      primary therapy, and at the time of disease recurrence. If patients remain vitamin D
      deficient at any of these follow-up time points, they will be referred to an endocrinologist
      for further work-up and treatment of their vitamin D deficiency. Data collection will
      continue for up to 1 year after enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment Related Morbidity
time frame: 1 year
description: Chemotherapy and 30-day post-operative surgical morbidity will be measured and reported in aggregate as number of patients with chemotherapy-related and/or surgery-related morbidity.
measure: Survival
time frame: 1 year
description: disease free survival
measure: Identify serum 25(OH)D and serum leptin relationship
time frame: baseline, at completion of primary cancer therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy
description: Change in serum 25(OH)D levels with vitamin D repletion
measure: Evaluate serum level changes
time frame: baseline, at completion of primary therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy]
description: Change in serum Leptin levels with vitamin D repletion
measure: Mutation Status
time frame: at time of enrollment
description: Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status
arm group label: Treatment
arm group type: Experimental
description: Vitamin D levels will be measured at the time of routine blood work. If Vitamin D levels are found to be low, patients will take 50,000 IU of vitamin D3 weekly daily as maintenance therapy. There is no prospective control arm.
intervention type: Drug
intervention name: Vitamin D3
description: Vitamin D3
arm group label: Treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Laura Holman, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No
provided document: 
provided document: 