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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

About this trial

This is an interventional basic science trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Isabelle Boquet, PhD

Phone

33 (0)4 91 22 37 78

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

GRAVIS Gwénaëlle, MD

12. IPD Sharing Statement

Plan to Share IPD

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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