Metastatic Ovarian Cancer
Conditions
Keywords
ovarian cancer, biomarker, metastatic
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.
Interventions
OTHERExperimental arm
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
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the predictive and prognostic value of HE4 marker | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed