HE4 as a Relapse Biomarker in Ovarian Cancers

Ovarian Carcinoma Clinical Trial

— PRONOV4IR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595281
• Other study ID #: 2014-A01511-46
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: July 18, 2022

Study information

• Verified date: December 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Other:
• Experimental arm
Serum samples are collected: at each neoadjuvant chemotherapy cycle before surgery at each adjuvant chemotherapy cycle at each injection of bevacizumab as maintenance therapy stop at the progression or after 24 months post chemotherapy

Locations

Country	Name	City	State
France	KALBACHER Elsa	Besançon	Hôpital Jean Minjoz
France	BENGRINE-LEVEVRE Leïla	Dijon	Centre Georges François Leclerc
France	LONGO Raphaelle	Metz	CHU Metz Thionville
France	SAVOYE Aude-Marie	Reims	Institut Jean Godinot
France	DEMARCHI Martin	Strasbourg	Centre Paul Strauss
France	KURTZ Jean-Emmanuel	Strasbourg	Hôpital Civil
France	GAVOILLE Céline	Vandœuvre-lès-Nancy	Institut De Cancérologie De Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the predictive and prognostic value of HE4 marker	Serum concentration of HE4 (pMol) will be analysed at each visit	24 months
Secondary	Compare the evolution of HE4 and CA-125 serum concentration	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	24 months
Secondary	Evaluate the progression-free survival at 18 months	HE4 and CA125 will be compared with the rate of progression-free survival	24 months
Secondary	Evaluate the quality of surgery	HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).	24 months