HE4 as a Relapse Biomarker in Ovarian Cancers (PRONOV4IR)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Ovarian Carcinoma

Treatments: Other: Experimental arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02595281

2014-A01511-46

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Study arm

Experimental group

Treatment:

Other: Experimental arm