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

CCTU- Cancer Theme

Status: Unknown

Conditions: Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02994511

CALIBRATE (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.