HE4 as a Relapse Biomarker in Ovarian Cancers

Not Applicable

Completed

• Conditions: Ovarian Carcinoma
• Interventions: Other: Experimental arm

• Registration Number: NCT02595281
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Study Start: 2016-04-01
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Exclusion Criteria

• Any previous treatment with platinum for ovarian carcinoma
• Patient with visceral metastases
• Contraindication for blood test
• Contraindication for surgery
• Contraindication for bevacizumab treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Experimental arm	-

Primary Outcome Measures

Name	Time	Method
To evaluate the predictive and prognostic value of HE4 marker	24 months	Serum concentration of HE4 (pMol) will be analysed at each visit

Secondary Outcome Measures

Name	Time	Method
Evaluate the quality of surgery	24 months	HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).
Compare the evolution of HE4 and CA-125 serum concentration	24 months	Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle
Evaluate the progression-free survival at 18 months	24 months	HE4 and CA125 will be compared with the rate of progression-free survival

Trial Locations

Locations (7)

BENGRINE-LEVEVRE Leïla; 🇫🇷 Dijon, Centre Georges François Leclerc, France

KALBACHER Elsa; 🇫🇷 Besançon, Hôpital Jean Minjoz, France

DEMARCHI Martin; 🇫🇷 Strasbourg, Centre Paul Strauss, France

LONGO Raphaelle; 🇫🇷 Metz, CHU Metz Thionville, France

KURTZ Jean-Emmanuel; 🇫🇷 Strasbourg, Hôpital Civil, France

SAVOYE Aude-Marie; 🇫🇷 Reims, Institut Jean Godinot, France

GAVOILLE Céline; 🇫🇷 Vandœuvre-lès-Nancy, Institut De Cancérologie De Lorraine, France