NCT02719041

Brief Summary

The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 13, 2016

Last Update Submit

March 20, 2016

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Responsive to IGF1R therapy

    Mean tumor volume will be calculated and growth inhibition will be reported as the percentage decrease of tumor volume compared with the control.

    One year

Study Arms (1)

Tissue samples

Tissue samples taken from women treated for ovarian cancer will be stained.

Other: Immunohistochemistry staining method

Interventions

Immunohistochemistry staining methodOTHER
Tissue samples

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The tissue and medical history of forty women who underwent surgery for ovarian cancer, at the Hillel Yaffe Medical Center

You may qualify if:

  • women who underwent surgery for ovarian cancer

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Ilan Bruchim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinat Lift, MSc

CONTACT

972-4-6304335rinatl@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2016

First Posted

March 25, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)