Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

Institut de Cancérologie de Lorraine7 sites in 1 country90 target enrollmentApril 1, 2016

ConditionsOvarian Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ovarian Carcinoma
Sponsor: Institut de Cancérologie de Lorraine
Enrollment: 90
Locations: 7
Primary Endpoint: To evaluate the predictive and prognostic value of HE4 marker
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

Registry

clinicaltrials.gov

Start Date

April 1, 2016

End Date

July 18, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut de Cancérologie de Lorraine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
•Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
•Age ≥ 18 years .
•Performance status ECOG \> or = 2
•Adequate haemoglobin rate ≥ 10 g/dL
•Ability to provide written informed consent
•Patient's legal capacity to consent to study participation