Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents
Primary Purpose
Kidney Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and tumor samples
Sponsored by
About this trial
This is an interventional basic science trial for Kidney Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient male or female, aged of more than 18 years
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)
- ECOG = 0 to 2
- Patient affiliated to, or beneficiary of, the national social security.
- Patient having signed informed consent
Exclusion Criteria:
- Patient previously treated with anti-angiogenic agents.
- 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.
- 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
Sites / Locations
- Institut Paoli CalmettesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
kidney cancer
Arm Description
Localized, oligometastatic or metastatic
Outcomes
Primary Outcome Measures
Plasma level of the MMP2 and MMP9 markers
ELISA assay
Survival without progression
date of progression (RECIST criteria), date of death
Secondary Outcome Measures
Full Information
NCT ID
NCT03185039
First Posted
June 9, 2017
Last Updated
January 8, 2020
Sponsor
Institut Paoli-Calmettes
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03185039
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
December 13, 2022 (Anticipated)
Study Completion Date
December 13, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
kidney cancer
Arm Type
Experimental
Arm Description
Localized, oligometastatic or metastatic
Intervention Type
Procedure
Intervention Name(s)
Blood and tumor samples
Intervention Description
Blood and tumor samples
Primary Outcome Measure Information:
Title
Plasma level of the MMP2 and MMP9 markers
Description
ELISA assay
Time Frame
at initial sampling
Title
Survival without progression
Description
date of progression (RECIST criteria), date of death
Time Frame
Up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient male or female, aged of more than 18 years
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)
ECOG = 0 to 2
Patient affiliated to, or beneficiary of, the national social security.
Patient having signed informed consent
Exclusion Criteria:
Patient previously treated with anti-angiogenic agents.
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
+33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle BOQUET, PhD
Phone
+33 4 91 22 37 78
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENRE Dominique, MD
Phone
33 (0)4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Boquet, PhD
Phone
33 (0)4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
GRAVIS Gwénaëlle, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21126687
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.
Results Reference
result
PubMed Identifier
24327581
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.
Results Reference
result
PubMed Identifier
26142442
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.
Results Reference
result
PubMed Identifier
26921265
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.
Results Reference
result
Links:
URL
http://institutpaolicalmettes.fr
Description
Official website of the sponsor
Learn more about this trial
Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents
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