Ovarian Carcinoma
Conditions
Keywords
Ovarian Carcinoma, neoadjuvant, ROMA, Ca125, HE4, biomarker
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.
Interventions
OTHERExperimental arm
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
Sponsors
Institut de Cancérologie de Lorraine
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the predictive and prognostic value of HE4 marker | 24 months | Serum concentration of HE4 (pMol) will be analysed at each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the evolution of HE4 and CA-125 serum concentration | 24 months | 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 | 24 months | HE4 and CA125 will be compared with the rate of progression-free survival |
| Evaluate the quality of surgery | 24 months | HE4 and CA125 will be compared with completeness of cancer resection score (CCR score). |
Countries
France
Outcome results
None listed