NCT03185039

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
May 2017Dec 2026

Study Start

First participant enrolled

May 29, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

9.6 years

First QC Date

June 9, 2017

Last Update Submit

March 18, 2026

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (2)

  • Plasma level of the MMP2 and MMP9 markers

    ELISA assay

    at initial sampling

  • Survival without progression

    date of progression (RECIST criteria), date of death

    Up to 18 months

Study Arms (1)

kidney cancer

EXPERIMENTAL

Localized, oligometastatic or metastatic

Procedure: Blood and tumor samples

Interventions

Blood and tumor samplesPROCEDURE

Blood and tumor samples

kidney cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Pregnant or nursing women 6- Contraindications to the procedure of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Publications (4)

  • 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.

    PMID: 21126687RESULT

  • 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.

    PMID: 24327581RESULT

  • 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.

    PMID: 26142442RESULT

  • 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.

    PMID: 26921265RESULT

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

May 29, 2017

Primary Completion (Estimated)

December 19, 2026

Study Completion (Estimated)

December 19, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)