NCT04284631

Brief Summary

To assess alterations of EGFR\& Her2neu expression in primary ovarian high grade serous carcinoma and its correlation with other clinicopathological parameters

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

April 1, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

February 22, 2020

Last Update Submit

March 30, 2020

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • EGFR& Her2neu expression to the grade of ovarian serous carcinoma

    EGFR\& Her2neu expression in primary ovarian high grade serous carcinoma

    2 years

  • EGFR& Her2neu expression in primary ovarian serous carcinoma to prognosis

    Expression of EGFR \& Her2neu in primary ovarian cancer to cancer free period

    5 years

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients with primary ovarian cancer
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergone exploratory laparotomy for primary ovarian cancer Sections 4μm thickness from newly formed tissue microarray blocks will be cut on coated slides then immunohistochemical staining using antibody against EGFR\& Her2neu will be done.

You may qualify if:

  • Patients with primary ovarian cancer

You may not qualify if:

  • patients with secondary ovarian cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pathology

Study Record Dates

First Submitted

February 22, 2020

First Posted

February 26, 2020

Study Start

January 1, 2012

Primary Completion

December 30, 2014

Study Completion

December 30, 2019

Last Updated

April 1, 2020

Record last verified: 2020-02