FAST study: Feasibility ASessment of circulating Tumour DNA (ctDNA) in the diagnosis of advanced lung cancer in patients

Not Applicable

Recruiting

Conditions: ung cancer
Lung cancer
Cancer - Lung - Non small cell

Registration Number: ACTRN12624000462583

Lead Sponsor: niversity of Otago

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.Participant is willing and able to give informed consent for participation in the trial.
2.Male or female, aged 18 years or above.
3.Radiological advanced lung cancer (distant metastases as per American Joint Committee on Cancer (AJCC) 8th edition Tumour, Nodes, Metastasis (TNM) staging, stage M1a, M1b or M1c)
4.Radiologist confirmed suspicion of malignancy on chest X-Ray (CXR) or computerised tomography (CT) and clinician opinion likely lung cancer primary
5.Not suitable for cytotoxic chemotherapy but fit for molecularly targeted treatment, due to patient comorbidity, performance status or patient preference
6.Unable to pursue molecular testing of a histological sample
a.Due to anatomical location/risk of complications or,
b.Due to patient preference or,
c.Due to insufficient material for molecular testing
7.Life expectancy expected more than 4 weeks
8.In the Investigator’s opinion, is able and willing to comply with all trial requirements.
9.Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria

•European Cooperative Oncology Group Performance status (ECOG PS) 4
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment rate of eligible patients over 12 months[Number of patients will be confirmed by audit of recruitment logs. At 12 months after the initiation of the study the number of patients recruited will be assessed. ];Proportion of patients with reportable ctDNA samples[Reportable ctDNA samples is defined by: <br>1)Oncogenic mutations detected (where an oncogenic mutation is identified);<br>2)Mutation not detected and; <br>3)Non-diagnostic sample (for a range of reasons including inadequate plasma, insufficient DNA). <br><br>This data will be collected by audit of the study database (which will contain anonymised patient medical records and outcome of molecular testing). 12 months after initiation of study]

Secondary Outcome Measures

Name	Time	Method
Turn around time for assay[Time from patient enrolment to time of assay result availability by assessment of electronic medical records Time from enrolment to time of assay result availability];Patient survey of ctDNA acceptability[Patients will be asked to complete a study-specific survey with questions at the time of blood test at the time of blood test];Clinician survey of ctDNA acceptability[Clinicians will be asked to complete a study-specific survey regarding the acceptability of the ctDNA test At the time of the blood test];Patient survival [Assessment of electronic medical records 3 months after enrolment into study.]