Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

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.

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Key information

Conditions

Metastatic Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié, Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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).

Treatment and study plan

Experimental Arm

Other

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

Primary outcomes

To evaluate the predictive and prognostic value of HE4 marker

Time frame: 18 months

Secondary outcomes

Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.

Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring

Acronym: Meta-Four

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2016
First posted: Jan 15, 2013
Registry last updated: Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed