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

NCT ID: NCT03185039

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2022-12-13

Brief Summary

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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

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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.

Conditions

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Kidney Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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kidney cancer

Localized, oligometastatic or metastatic

Group Type EXPERIMENTAL

Blood and tumor samples

Intervention Type PROCEDURE

Blood and tumor samples

Interventions

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Blood and tumor samples

Blood and tumor samples

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Paoli Calmettes

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique GENRE, MD

Role: CONTACT

+33 4 91 22 37 78

Isabelle BOQUET, PhD

Role: CONTACT

+33 4 91 22 37 78

Facility Contacts

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GENRE Dominique, MD

Role: primary

33 (0)4 91 22 37 78

Isabelle Boquet, PhD

Role: backup

33 (0)4 91 22 37 78

References

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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.

Reference Type RESULT
PMID: 21126687 (View on PubMed)

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.

Reference Type RESULT
PMID: 24327581 (View on PubMed)

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.

Reference Type RESULT
PMID: 26142442 (View on PubMed)

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.

Reference Type RESULT
PMID: 26921265 (View on PubMed)

Related Links

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http://institutpaolicalmettes.fr

Official website of the sponsor

Other Identifiers

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MMP-Rein-IPC 2015-029

Identifier Type: -

Identifier Source: org_study_id

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