Assessment of NSW Early Clinical Trials Alliance Network Assistance in Cancer Trials Access

Patients with advanced/refractory cancer will be referred for access and enrolment to clinical trials in New South Wales through the NSW Early Clinical Trials Alliance (NECTA) network. The study will determine the benefits of genomic profiling in a subset of patients referred for early phase clinical trials to NECTA using a ctDNA assay. 1. Patients will be asked to provide initial informed consent to collect information and perform other screening procedures for consideration of early phase clinical trial across the trial sites as well as consideration for the ctDNA assay (if they have an eligible tumour type) 2. Oncology Clinician confirms eligibility and ECOG status within 7 days prior to consent. 3. Follow up patient status does not require a patient visit; data will be collected from medical records or linkage with other databases Details of Assessments 1. Informed patient consent - prior to enrolment Informed patient consent will be obtained to participate in the study and to perform the ctDNA assay where eligible. 2. Clinician referral of patient - at time point of enrolment A baseline core clinical dataset will be captured on all patients referred to the NECTA network who intend on undergoing genomic profiling to ensure patients meet the eligibility criteria. Patient status including stage and type of tumour, disease status and previous line of treatments will be recorded. The information will be entered into a secure database/paper or electronic record managed by NECTA and by the individual sites that patients are being recruited from. 3. Retrieval of archival biospecimens - at time point of enrolment Optional consent will be requested for retrieval of archival tumour tissue samples where available for future, unspecified research including genomics, transcriptomics and proteomics assays. 4. Biospecimen collection and processing - within 7 days of enrolment ctDNA Assay: A sample of peripheral blood (10 mLs, in 2 test tubes) will be obtained from each participant who consent to PANNA-COTA and are eligible for the assay within 7 days of trial enrolment. The blood sample will be sent to a central laboratory for testing. 5. Clinical assessment including previous lines of treatment - within 2 weeks following enrolment A core clinical dataset will be collected on all patients including Patient’s ECOG Status, comorbidities, stage and tumour type, previous lines of treatment and their response to those treatment will be recorded. 6. Tumour Board (TB) review and recommendation - within 4 weeks following enrolment Referring oncologists will obtain the ctDNA report result and be able to make Phase 1 trial recommendations upon receipt of the result, if there is a suitable trial available to that clinician. If there is no suitable trial, the results will be discussed at the Tumour Board which will meet on a fortnightly basis. Individual patient screening results will be presented in conjunction with an overview of the patient's clinical information. Genomic results, clinical information and their demographics will be reviewed by oncologists and considered when determining individual clinical trial recommendations across the NECTA network. The TB report will be provided to the patients’ referring clinician and trials team. 7. Questionnaires - within 8 weeks of enrolment Psychosocial questionnaires and interviews Questionnaires will be used to evaluate clinicians’ understanding and expectations of clinical trial enrolment and impact of ctDNA results will be collected at study registration (into screening phase) and additional time points after return of screening. A questionnaire will be used to evaluate patients’ understanding and expectations of clinical trial enrolment and impact of ctDNA results and will be collected following prospective trial enrolment. 8. Follow up - beginning immediately post enrolment and up to 2 years following enrolment Patient will be requested to allow their ongoing health status to be periodically reviewed via continued study visits or phone contact or from their general practitioner, or medical records, state-based cancer registries and/or the national mortality registry (AIHW). Participants may be referred back to the Tumour Board for further recommendations if they are unable to be enrolled in initial trial options or treatment is unsuccessful. There is no set waiting or washout period as part of this study.