Clinical trial NCT03185039: Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents
Official title: Study of the Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents Compared to Patients Not Treated With Antiangiogenic (Localized Kidney Cancer and Oligometastatic)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma level of the MMP2 and MMP9 markers
timeFrame: at initial sampling
measure: Survival without progression
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
References:
citation: Jubb AM, Harris AL. Biomarkers to predict the clinical efficacy of bevacizumab in cancer. Lancet Oncol. 2010 Dec;11(12):1172-83. doi: 10.1016/S1470-2045(10)70232-1.
citation: Tabouret E, Boudouresque F, Barrie M, Matta M, Boucard C, Loundou A, Carpentier A, Sanson M, Metellus P, Figarella-Branger D, Ouafik L, Chinot O. Association of matrix metalloproteinase 2 plasma level with response and survival in patients treated with bevacizumab for recurrent high-grade glioma. Neuro Oncol. 2014 Mar;16(3):392-9. doi: 10.1093/neuonc/not226. Epub 2013 Dec 9.
citation: Tabouret E, Boudouresque F, Farina P, Barrie M, Bequet C, Sanson M, Chinot O. MMP2 and MMP9 as candidate biomarkers to monitor bevacizumab therapy in high-grade glioma. Neuro Oncol. 2015 Aug;17(8):1174-6. doi: 10.1093/neuonc/nov094. No abstract available.
citation: Tabouret E, Bertucci F, Pierga JY, Petit T, Levy C, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, van Laere S, Ueno NT, Toiron Y, Finetti P, Birnbaum D, Borg JP, Viens P, Chinot O, Goncalves A. MMP2 and MMP9 serum levels are associated with favorable outcome in patients with inflammatory breast cancer treated with bevacizumab-based neoadjuvant chemotherapy in the BEVERLY-2 study. Oncotarget. 2016 Apr 5;7(14):18531-40. doi: 10.18632/oncotarget.7612.