Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents

Kidney Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03185039
• Other study ID #: MMP-Rein-IPC 2015-029
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2017
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33 4 91 22 37 78
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Procedure:
• Blood and tumor samples
Blood and tumor samples

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Review. — View Citation

Tabouret E, Bertucci F, Pierga JY, Petit T, Levy C, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roché H, Bachelot T, van Laere S, Ueno NT, Toiron Y, Finetti P, Birnbaum D, Borg JP, Viens P, Chinot O, Gonçalves A. MMP2 and MMP9 serum levels are associa — View 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 be — View Citation

Tabouret E, Boudouresque F, Farina P, Barrié 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma level of the MMP2 and MMP9 markers	ELISA assay	at initial sampling
Primary	Survival without progression	date of progression (RECIST criteria), date of death	Up to 18 months

External Links

•   Official website of the sponsor