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

Institut Paoli-Calmettes

Status: Unknown

Conditions: Kidney Cancer

Treatments: Procedure: Blood and tumor samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03185039

MMP-Rein-IPC 2015-029

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

kidney cancer

Experimental group

Description:

Localized, oligometastatic or metastatic

Treatment:

Procedure: Blood and tumor samples