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The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846856
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Tracking Information
First Submitted Date February 18, 2019
First Posted Date February 20, 2019
Last Update Posted Date April 4, 2019
Estimated Study Start Date April 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2019)
Involvement of IGF Axis in Ovarian Cancer [ Time Frame: Two years ]
Ovarian cancer specimens taken during surgical procedures will be evaluated and analyzed by flow cytometry assays to determine the involvement of the IGF axis in the immune tumor microenvironment in ovarian cancer
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
Official Title The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
Brief Summary The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients diagnosed with epithelium ovarian cancer who have undergone or who plan to undergo surgery
Condition Ovarian Cancer
Intervention Other: Biopsy
Biopsy taken during surgical procedure
Study Groups/Cohorts Ovarian cancer patients
Biopsy will be taken from ovarian cancer patients and sent to laboratory for analysis
Intervention: Other: Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 18, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women diagnosed with epithelium ovarian cancer who have undergone surgery

Exclusion Criteria:

  • Pregnant women
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hagit Stolz, DVM 972-4-7744335 hagitst@hy.health.gov.il
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03846856
Other Study ID Numbers HYMC-0080-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hillel Yaffe Medical Center
Study Sponsor Hillel Yaffe Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Ilan Bruchim, MD Hillel Yaffe Medical Center
PRS Account Hillel Yaffe Medical Center
Verification Date April 2019