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Prediction of response to kinase inhibitors based on protein phosphorylation profiles in tumor tissue from advanced renal cell cancer patients.

Prediction of response to kinase inhibitors based on protein phosphorylation profiles in tumor tissue from advanced renal cell cancer patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26770
Enrollment
225
Registered
2012-11-14
Start date
2012-11-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phosphoproteomics - phosphoproteomics Response prediction - therapieselectie renal cell cancer - nierkanker kinase inhibitors - kinaseremmers

Interventions

In this study, a fresh tumor biopsy from a metastasis or a primary tumor will be taken. In all subjects subsequent standard treatment will be initiated according to current clinical guidelines. In add

Sponsors

VU Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with advanced (unresectable and/or metastatic) renal cell cancer; 2. Patients who will start treatment with sunitinib, pazopanib, sorafenib, axitinib or everolimus; 3. At least one tumor lesion should be accessible for biopsy. bone metastases are excluded as possible biopsy site; 4. Age >- 18 years; 5. Patients must have at least one measurable lesion. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST); 6. WHO performance status 0 - 2; 7. Able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Clinical findings associated with an unacceptably high tumor biopsy risk, according to the judgement of the investigator; 2. Radiotherapy on target lesions during study or within 4 weeks of the start of study drug; 3. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Design outcomes

Primary

MeasureTime frame
The phosphoproteomics profile of the tumor biopsy before treatment will be determined and correlated with radiological response and progression-free survival.

Secondary

MeasureTime frame
1. The relationship between the PamChip kinase activity profile for the initiation of therapy and progression-free survival; 2. The relationship between the genetic mutation profile of the primary tumor based on MPS and progression-free survival; 3. The relationship between the serum peptide profile before and during treatment and progression-free survival; 4. The relationship between the number and type of immune regulatory cells in blood and tissue and progression-free survival; 5. The relationship between genetic polymorphisms and pharmacokinetic parameters and progression-free survival; 6. The relationship between protein profile tumorexosomen from urine and serum and progression-free survival.

Contacts

Public ContactH.M.W. Verheul

De Boelelaan 1117

h.verheul@vumc.nl+31 (0)20 4444321/300

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)