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

NCT02994511 | Unknown

• 1 other identifier: CALIBRATE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Circulating tumour DNA; ctDNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acceptability of research sampling

  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

  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

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients potentially eligible for early phase experimental therapeutic trials will be invited to take part in this study.

You may qualify if:

• 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)

You may not qualify if:

• Age below 18 years old
• Patient not physically and mentally able to give informed consent.

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• AstraZeneca: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour samples Blood Samples ctDNA isolated from bloods samples

MeSH Terms

Conditions

Neoplasms

Study Officials

• Richard Baird

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Bax

CONTACT

lisa.bax@addenbrookes.nhs.uk

Richard Baird

CONTACT

rdb39@medschl.cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Richard Baird

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: December 16, 2016
• Study Start: December 8, 2014
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

GB (1)