Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer
Meta-Four
Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
2 other identifiers
interventional
101
1 country
2
Brief Summary
HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2010
CompletedFirst Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2016
CompletedOctober 20, 2020
October 1, 2020
5 years
January 9, 2013
October 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the predictive and prognostic value of HE4 marker
18 months
Secondary Outcomes (1)
Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.
18 months
Study Arms (1)
Study arm
EXPERIMENTALInterventions
Serum samples are collected: * at time of diagnosis of recurrence (before 1st chemotherapy) * during each cycle of chemotherapy * after the end of chemotherapy * every 3 month until treatment failure (3-6 samples) * stop at the progression or after 18 months post chemotherapy
Eligibility Criteria
You may qualify if:
- Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
- Recurrence of anytime necessitating a new line of chemotherapy
- Patient having received adjuvant chemotherapy
- Informed consent signed prior any study specific procedures
You may not qualify if:
- More than 3 lines of chemotherapy
- Pregnancy or breastfeeding
- History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
- Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institut Bergonié
Bordeaux, 33076, France
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, 34298, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
January 9, 2013
First Posted
January 15, 2013
Study Start
September 24, 2010
Primary Completion
September 22, 2015
Study Completion
November 15, 2016
Last Updated
October 20, 2020
Record last verified: 2020-10