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HE4 as a Relapse Biomarker in Ovarian Cancers (PRONOV4IR)

Primary Purpose

Ovarian Carcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental arm
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Carcinoma focused on measuring Ovarian Carcinoma, neoadjuvant, ROMA, Ca125, HE4, biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • BENGRINE-LEVEVRE Leïla
  • DEMARCHI Martin
  • LONGO Raphaelle
  • KURTZ Jean-Emmanuel
  • KALBACHER Elsa
  • GAVOILLE Céline
  • SAVOYE Aude-Marie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Evaluate the progression-free survival at 18 months
HE4 and CA125 will be compared with the rate of progression-free survival
Evaluate the quality of surgery
HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).

Full Information

First Posted
November 2, 2015
Last Updated
December 16, 2022
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02595281
Brief Title
HE4 as a Relapse Biomarker in Ovarian Cancers
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma
Keywords
Ovarian Carcinoma, neoadjuvant, ROMA, Ca125, HE4, biomarker

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Experimental arm
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the predictive and prognostic value of HE4 marker
Description
Serum concentration of HE4 (pMol) will be analysed at each visit
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Compare the evolution of HE4 and CA-125 serum concentration
Description
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
Time Frame
24 months
Title
Evaluate the progression-free survival at 18 months
Description
HE4 and CA125 will be compared with the rate of progression-free survival
Time Frame
24 months
Title
Evaluate the quality of surgery
Description
HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline Gavoille, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
BENGRINE-LEVEVRE Leïla
City
Dijon
State/Province
Centre Georges François Leclerc
ZIP/Postal Code
21 079
Country
France
Facility Name
DEMARCHI Martin
City
Strasbourg
State/Province
Centre Paul Strauss
ZIP/Postal Code
67065
Country
France
Facility Name
LONGO Raphaelle
City
Metz
State/Province
CHU Metz Thionville
ZIP/Postal Code
57085
Country
France
Facility Name
KURTZ Jean-Emmanuel
City
Strasbourg
State/Province
Hôpital Civil
ZIP/Postal Code
67 091
Country
France
Facility Name
KALBACHER Elsa
City
Besançon
State/Province
Hôpital Jean Minjoz
ZIP/Postal Code
25 030
Country
France
Facility Name
GAVOILLE Céline
City
Vandœuvre-lès-Nancy
State/Province
Institut De Cancérologie De Lorraine
ZIP/Postal Code
54 519
Country
France
Facility Name
SAVOYE Aude-Marie
City
Reims
State/Province
Institut Jean Godinot
ZIP/Postal Code
51 056
Country
France

12. IPD Sharing Statement

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HE4 as a Relapse Biomarker in Ovarian Cancers

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