HE4 as a Relapse Biomarker in Ovarian Cancers

NCT02595281 | Completed DMC

• 1 other identifier: 2014-A01511-46
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

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.

Conditions

Ovarian Carcinoma

Keywords

Ovarian Carcinoma; neoadjuvant; ROMA; Ca125; HE4; biomarker

Outcome Measures

Primary Outcomes (1)

• To evaluate the predictive and prognostic value of HE4 marker

  Serum concentration of HE4 (pMol) will be analysed at each visit

  24 months

Secondary Outcomes (3)

• Compare the evolution of HE4 and CA-125 serum concentration

  24 months

• Evaluate the progression-free survival at 18 months

  24 months

• Evaluate the quality of surgery

  24 months

Study Arms (1)

Study arm

EXPERIMENTAL

Other: Experimental arm

Interventions

Experimental arm OTHER

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

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (7)

BENGRINE-LEVEVRE Leïla

Dijon, Centre Georges François Leclerc, 21 079, France

Location

DEMARCHI Martin

Strasbourg, Centre Paul Strauss, 67065, France

Location

LONGO Raphaelle

Metz, CHU Metz Thionville, 57085, France

Location

KURTZ Jean-Emmanuel

Strasbourg, Hôpital Civil, 67 091, France

Location

KALBACHER Elsa

Besançon, Hôpital Jean Minjoz, 25 030, France

Location

GAVOILLE Céline

Vandœuvre-lès-Nancy, Institut de Cancérologie de Lorraine, 54 519, France

Location

SAVOYE Aude-Marie

Reims, Institut Jean Godinot, 51 056, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Céline Gavoille, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: April 1, 2016
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

FR (7)