Cancer Clinical Trial - Cambridge Liquid Biopsy & Tumour Profiling Study

Status Recruiting

Clinical Trial Summary

This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive factor of response/resistance to anticancer treatment. The project will involve the collection and study of the archived tumour tissue where available (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an early phase clinical trial.

Clinical Trial Description

Some patients respond to anti-cancer drugs whilst others do not, despite having tumours with, apparently, similar characteristics such as site of origin. This variability in response can in some cases be explained by the genetic profile of the tumour. Therefore, studying the relationship between the molecular profiles of individual cancers and the response to therapy over time is of crucial importance in drug development. However, this endeavour is hampered by the difficulty in accessing suitable tumour material for analysis. Many patients' tumours are at anatomical sites which make biopsy difficult / hazardous which is in addition to the discomfort of a biopsy procedure. Therefore, this study will explore the potential of the circulating tumour DNA as a predictive factor of response/resistance to anticancer treatment.

For patients recruited to early phase clinical trials of experimental therapies, archival tumour tissue (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) will be collected according to the individual schedule of each clinical trial.

Blood plasma samples will be tested for cell-free and ctDNA levels and genomic profiles, which may include analyses of mutational profiles, copy number variations, translocations, chromosomal rearrangements and/or epigenetic profiles.

Molecular profiling of archival and fresh tumour biopsies will also be carried out to study the correlation with cell-free and ctDNA samples and investigate the potential predictor response/resistance to treatment. ;

Study Design

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT02994511
Study type	Observational
Source	Cambridge University Hospitals NHS Foundation Trust
Contact	Lisa Bax
Email	lisa.bax@addenbrookes.nhs.uk
Status	Recruiting
Phase
Start date	December 8, 2014
Completion date	March 30, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials — CALIBRATE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms