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Metabolomic Profiling in Renal Cell Carcinoma

NCT02001493 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-06-23

No results posted yet for this study

Summary

Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy. Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that are useful surrogates for clinical response and also to identify patients early on who will benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in patients and also in reducing cost implications of this expensive group of drugs.

The investigators wish to explore the variability of baseline metabolomic profile in the blood and urine of patients with mRCC and characterise the inter-subject and intra-subject variability. The study of the baseline levels has not been performed in this cohort previously. This is extremely important in interpreting the emerging data of changes in the levels of the various biomarkers from various trials. This will in turn help in the development of future targeted therapies, especially Phase I/II studies where an early demonstration of target modulation is vital. This study will also help to identify the number of patients required for appropriate statistical evaluation in pharmacodynamic studies to assess biological activity, optimisation of dosing, and investigation of potential mechanisms of resistance. Study of the urinary and blood metabolomic profile in conjunction will give us an insight into the potential use of urine as a diagnostic and prognostic tool.

OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after nephrectomy or antiangiogenic treatment during 2 months

Conditions

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • TIm Eisen, Professor · University of Cambridge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001493 on ClinicalTrials.gov