Embedding Research (and evidence) in Cancer Healthcare (EnRICH) - Program Protocol

Abstract

Program title: Embedding Research (and evidence) in Cancer Healthcare (EnRICH) Short title: EnRICH Protocol number and date: X16-0447 dated 08/12/2020 Aim: The aim of this Sydney Catalyst flagship program is to assemble a patient cohort to: describe the natural history of and patterns of care for lung cancer; identify current gaps in evidence and practice for clinical quality improvement; create a platform for researchers across the T1-T3 translational research spectrum to develop and initiate clinical research and intervention studies to address gaps. Initially lung cancer will be an exemplar. Design: Prospective clinical cohort of lung cancer patients including matched demographic, clinical, biomarker, molecular profile, and outcome data (including quality of care and patient-reported outcomes) for current and future research projects. Planned sample size: At least 1000 patients Inclusion criteria: All patients with lung cancer presenting to defined clinical sites for diagnosis or treatment, including: (i) Patients with a new diagnosis of primary lung cancer (any histological type, any pathological/clinical stage including metastatic) undergoing primary treatment; curative or palliative (ii) Patients with first progressive disease, local recurrence or new metastasis after completing previous treatment for non-metastatic disease at the time of initial diagnosis (iii) Aged over 18 years Data and biospecimen collection 1. Matched clinical and demographic data will be collected from patient medical records and hospital administrative data sets 2. Archival tissue, for research, will be obtained from routine biopsy specimens. Serial blood samples for research, on average 3 per patient (e.g. prior to commencement of treatment [baseline], and post-treatment [6 and 12 month follow-up]) 3. Patient reported outcomes will be measured through questionnaires Statistical considerations: The cohort will enable reliable estimates of outcomes both overall and within histologic and genetic sub-types. Program duration: At least 5 years