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

Not Applicable

• Conditions: Kidney Cancer
• Interventions: Procedure: Blood and tumor samples

• Registration Number: NCT03185039
• Lead Sponsor: Institut Paoli-Calmettes

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.

Study Timeline

• Study Start: 2017-05-29
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kidney cancer	Blood and tumor samples	Localized, oligometastatic or metastatic

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, France