Kidney Cancer
Conditions
Brief summary
Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or Pazopanib).
Detailed description
The objective is to analyze the predictive impact of circulating MMP2 and MMP9 on the progression-free survival of patients with metastatic kidney cancer treated with anti-angiogenic agents (Sunitinib or Pazopanib) in comparison with two untreated cohorts (localized or oligometastatic cancer). Prospective monocenter, open-label study In the frame of disease management blood samples will be collected at different times of follow-up regarding disease status (localized, oligometastatic and metastatic) and tissue samples will be collected for patients scheduled for surgery.
Interventions
PROCEDUREBlood and tumor samples
Blood and tumor samples
Sponsors
Institut Paoli-Calmettes
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient male or female, aged of more than 18 years 2. Patient with any of the following conditions: * Kidney cancer localized at diagnosis. * Metastatic kidney cancer when anti-angiogenic therapy is initiated by Sunitinib or Pazopanib * Oligometastatic kidney cancer without systemic treatment (local treatment) 3. ECOG = 0 to 2 4. Patient affiliated to, or beneficiary of, the national social security. 5. Patient having signed informed consent
Exclusion criteria
1. Patient previously treated with anti-angiogenic agents. 2. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent. 3. Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons 4. History of malignant disease in the 5 years prior to inclusion (except basal cell carcinoma of the skin or epithelioma of the cervix in situ, or prostate cancer with a good prognosis (stage T \<3 and Gleason \<7)) accidentally discovered during the histological analysis of the tumor sample. 5- Pregnant or nursing women 6- Contraindications to the procedure of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma level of the MMP2 and MMP9 markers | at initial sampling | ELISA assay |
| Survival without progression | Up to 18 months | date of progression (RECIST criteria), date of death |
Countries
France
Outcome results
None listed