Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

NCT01339975 | Completed

• 1 other identifier: CHUBX 2010/45
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research. The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

Conditions

Carcinoma; Carcinoma Renal Cell; Kidney Neoplasms; Kidney Diseases; Chemokines

Keywords

Renal Cell Carcinoma; Nephrectomy; Antiangiogenics; Chemokines; Prognostic value; Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Kidney Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Adjuvants, Immunologic; Physiological Effects of Drugs; Pharmacologic Actions; Biomarkers; Targeted therapies; Surgery

Outcome Measures

Primary Outcomes (1)

• Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)

  Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence. Localized or locally advanced renal cell carcinoma group: * local recurrence * contralateral recurrence * extra-renal distant recurrence (metastatic progression) * specific cancer death * nonspecific cancer death Metastatic renal cell carcinoma group : * local recurrence for patients who underwent a nephrectomy * contralateral reccurence * metastatic progression * specific cancer death * nonspecific cancer death

  3 years

Secondary Outcomes (1)

• Predictive value of therapeutic response

  3 years

Study Arms (2)

Group A. Surgically treated patients

Patients having a radical or partial nephrectomy.

Biological: Biological sample

Group B. Patients treated with targeted therapies

Patients treated by RCC-directed targeted therapy

Biological: Biological sample

Interventions

Biological sample BIOLOGICAL

2 blood samples of 10mL + one urine sample * on pre-operative d-1/d, post-operative d1 and d5(+/-2), * one month post-operative, * at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.

Group A. Surgically treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma

You may qualify if:

• Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma :
• having a radical or partial nephrectomy
• or treated by RCC-directed targeted therapy
• Patients who have signed and dated an informed consent form with the investigator

You may not qualify if:

• under 18 years old

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Bordeaux Hospital

Bordeaux, 33076, France

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine and tissues

MeSH Terms

Conditions

Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Kidney Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jean-Christophe BERNHARD, Dr

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 21, 2011
• Study Start: June 6, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)