Molecular Determinants for Therapy Response on Renal Cell Carcinoma

NCT02208128 | Unknown DMC

• 2 other identifiers: S-539/2013DRKS00006193
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the scientific analysis is to find biological factors (biomarkers) allowing a prediction of disease progression and a better choice of therapy. After diagnosis the kidney and the tumor will be removed by standard surgery followed by drug therapy. Within surgery remaining tumor tissue will be used for the scientific analysis. In case of disease progression during the drug treatment the drug therapy will be changed. Before therapy change a small tissue sample will be collected for molecular diagnostics. This will be done by puncture through the skin under local anesthesia. Blood samples taken before surgery and at the time of first and second disease progression will also be used for molecular-biological analysis. As there is no clear recommendation for drug therapy after disease progression this study should serve to determine an individual therapy on the basis of the molecular profile and the molecular changes. As the tumor disease changes and developes resistance to drugs, analysis at the time of disease progression shall identify biological factors which will predict a likelihood response to a specific drugs. This shall allow to give the patient an individual therapy.

Conditions

Renal Cell Carcinoma

Keywords

Renal cell carcinoma; Biomarkers; Molecular modifications

Outcome Measures

Primary Outcomes (1)

• Time to disease progression in third line therapy

  Progression free survival in third-line therapy ( defined as the time from beginning of the third-line therapy to the date of the first documented progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors criteria assessed by CT/MRI every 12 weeks).

  Approximately 2 years depending on when the failure in third line therapy happens

Secondary Outcomes (1)

• Identification of preventive biomarkers.

  2weeks in average before surgery and 4 weeks in average after surgery before starting first line treatment

Other Outcomes (1)

• Identification of preventive biomarkers

  2years

Study Arms (1)

Receptor-Tyrosinkinase-Inhibitor

NO INTERVENTION

Guidelines-oriented therapy with approved systemic medications for renal cell carcinoma individually for each patient (Receptor-Tyrosinkinase-Inhibitor) (e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus, Axitinib, Temsirolimus). With 1.progression turning to second line treatment with one of the upper mentioned medications. Third line therapy due to the individual molecular modifications for each patient.

Drug: Sunitinib, Pazopanib, Bevacizumab, Everolimus...

Interventions

Sunitinib, Pazopanib, Bevacizumab, Everolimus... DRUG

Clinical standard

Also known as: e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus...

Receptor-Tyrosinkinase-Inhibitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum Age: 18 Years Maximum Age: no maximum age
• metastatic lesions easy of access for puncture for specimen storage
• histological subtype: clear-cell renal cancer
• no contraindications against systemic therapy
• indication for systemic therapy given

You may not qualify if:

• preexisting mental illness
• further active malignancy
• patients with increased risk of bleeding and/or wound healing disorder
• patients who are not legally competent or unable to consent
• contraindication for surgical intervention

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Urological Department of the University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib; pazopanib; Bevacizumab; Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Sascha Pahernil, PD Dr.

  University of Heidelberg, Urological Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha Pahernik, PD Dr.

CONTACT

+49 6221 5639689; sascha.pahernik@med.uni-heidelberg.de

Carsten Grüllich, PD Dr.

CONTACT

+49 6221 5637125; carsten.gruellich@med.uni-heidelberg.de

Study Design

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

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: August 4, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 4, 2014

Record last verified: 2014-07

Locations

DE (1)