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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Histological or cytological confirmation of cancer Patient being considered for participation in an experimental therapeutic trials Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule (such conditions should be discussed with the patient before registration in the study) Exclusion criteria: Age below 18 years old Patient not physically and mentally able to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the change in circulating tumor DNA [ctDNA] levels of patients on experimental therapeutic trials. | ctDNA levels will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer. | From baseline to the end of study, defined as 'disease progression or evidence of unacceptable toxicity', whichever comes first, measured at the start of each cycle (cycle = approximately 3 weeks) and CT scan (every 2 cycles), for up to 100 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of research sampling | Acceptability of research tumour biopsies will be assessed by providing a patient with an 'Acceptability Questionnaire' pre and post biopsy. | Optional fresh tissue biopsies are planned to be taken at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months. | 
| Safety of tumour biopsies for patients with cancer on experimental therapeutic trials | Serious Adverse events at least possibly related to the research biopsy procedure will be collected prospectively. In addition, information related to the medical history and biopsy procedure will be recorded at the different time points. | Assessed at baseline, at the CT scan day for evaluation of response (every 2 cycles (cycle = approximately 3 weeks)) and after disease progression is confirmed, for up to 100 months. | 
| Gene Mutation profiles in ctDNA and tumour biopsies (where available) over time for patients with cancer on experimental therapeutic trials | Gene mutation profiles will be compared to clinical, pathological and radiological data to assess relationship to response and progression of cancer. | From baseline, at the time points specified in Outcomes 1 and 2, until the end of study, defined as 'disease progression or evidence of unacceptable toxicity', for up to 100 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumour DNA, ctDNA