Molecular Determinants for Therapy Response on Renal Cell Carcinoma

  • STATUS
    Recruiting
  • participants needed
    4
  • sponsor
    Heidelberg University
Updated on 8 November 2020
cancer
sunitinib
systemic therapy
carcinoma
everolimus
biological factors
bevacizumab
kidney cancer
pazopanib

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.

Description

Aim of this study is to perform a profound molecular analysis of the tumor before beginning therapy and after failure of the approved targeted first-and second line therapy (standard therapy). The tumor sample will be analyzed by using profound molecular analysis to identify target structures which will predict the efficacy of a specific therapy (substance group)and therefore have a predictive value. The analysis of molecular biomarkers include the genomic sequencing of targeted areas or of the entire DNA of the tumor tissue comparative to the DNA of healthy cells, the measurement of DNA-regulatory elements (methylation, mi-RNA expression, protein expression analytics, functional tumorcell analysis in-vitro, efficacy analysis in cell culture or in animal model) who are supposed to inspect the biological influence of the molecular biomarkers and measurements of free tumor DNA out of the blood.

The response to the established standard therapy in the first and second line will be acquired due to all clinical and radiological established standard parameters. The clinical-radiological response will be correlated with the molecular changes and their changes in therapy process to allow predictive prognosis for a further therapy.

There is no approved clinical standard for third line therapy. However there are further medications approved without any scientific evidence of their efficacy in this therapy situation (third line treatment after failure of first and second line treatment) and for which a response of under 6 weeks is expected.

For these patients the third line therapy will be adjusted to the molecular profiles of the previous therapies. Therefore the oncological history of the noticed marker profiles and the presence of target structures (from whom it is known that they are influenced by certain substances) will be considered.

The therapy will use substances which are approved in general for the treatment of metastatic renal cell cancer.

Details
Condition Renal Cell Carcinoma
Treatment Sunitinib, Pazopanib, Bevacizumab, Everolimus...
Clinical Study IdentifierNCT02208128
SponsorHeidelberg University
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Renal Cell Carcinoma?
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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note