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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03185039
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : January 10, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Kidney Cancer Procedure: Blood and tumor samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : December 13, 2022
Estimated Study Completion Date : December 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: kidney cancer
Localized, oligometastatic or metastatic
Procedure: Blood and tumor samples
Blood and tumor samples




Primary Outcome Measures :
  1. Plasma level of the MMP2 and MMP9 markers [ Time Frame: at initial sampling ]
    ELISA assay

  2. Survival without progression [ Time Frame: Up to 18 months ]
    date of progression (RECIST criteria), date of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185039


Contacts
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Contact: Dominique GENRE, MD +33 4 91 22 37 78 drci.up@ipc.unicancer.fr
Contact: Isabelle BOQUET, PhD +33 4 91 22 37 78

Locations
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France
Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Contact: GENRE Dominique, MD    33 (0)4 91 22 37 78    drci.up@ipc.unicancer.fr   
Contact: Isabelle Boquet, PhD    33 (0)4 91 22 37 78    drci.up@ipc.unicancer.fr   
Principal Investigator: GRAVIS Gwénaëlle, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Institut National de la Santé Et de la Recherche Médicale, France
Additional Information:
Publications of Results:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03185039    
Other Study ID Numbers: MMP-Rein-IPC 2015-029
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type