Cancer Clinical Trial
— CALIBRATEOfficial title:
Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials
NCT number | NCT02994511 |
Other study ID # | CALIBRATE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 8, 2014 |
Est. completion date | March 30, 2020 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
CCTU- Cancer Theme | AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. |
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