GoKawiilPatient cohort
The PEACE study
PEACE is a pan-cancer, UK-wide research autopsy programme (https://clinicaltrials.gov/study/NCT03004755) designed to investigate the biology of metastatic disease and drug resistance. The study was sponsored by the University College London (UCL) Clinical Trials Centre and approved by the Health Research Authority National Research Ethics Service Committee London–Dulwich on 15 August 2013, in accordance with the UK Human Tissue Act 2004, with research ethics committee reference 13/LO/0972. Informed consent was provided by patients during life or by a person in a qualifying relationship after death.
Eligibility was defined by the following inclusion criteria: (1) age 18 years or over; (2) confirmed solid malignancy with metastatic disease (where the site of origin is known or unknown), with the exception of primary brain tumours, in which there might not be evidence of metastatic disease; and (3) oral and written informed consent from patient to enter the study and to undergo tissue collection after death or from a nominated representative or a person in a qualifying relationship after the patient has died. Exclusion criteria were: (1) medical or psychiatric condition that would preclude informed consent; (2) history of intravenous drug abuse within the past five years; or (3) confirmed diagnosis of known high-risk infections (for example, HIV/AIDS-positive, hepatitis B or C, tuberculosis and Creutzfeldt–Jacob disease), unless the patient case is of particular scientific interest and was agreed in advance with local mortuary staff and pathologist.
The TRACERx–PEACE lung cohort
The TRACERx study (https://clinicaltrials.gov/ct2/show/NCT01888601) is a prospective observational cohort study approved by an independent research ethics committee (13/LO/1546). The inclusion and exclusion criteria, clinical data acquisition and tissue and plasma sampling procedures have been described18,19. In brief, the TRACERx study includes patients with histopathologically confirmed early-stage I–IIIB NSCLC who underwent primary surgery. Patients are followed up after surgery, during which longitudinal clinical data, plasma and, in the case of disease relapse or progression, tissue samples are collected.
Forty-nine patients with NSCLC were enrolled in both TRACERx and PEACE; 41 died and 33 underwent a research autopsy (Supplementary Fig. 1). Research autopsies were not performed owing to lack of death notification (n = 6), post-mortem withdrawal of consent (n = 1) or COVID-19 restrictions (n = 1).
No tumour was identified in four patients who underwent an autopsy after pathological assessment. In three patients, WES data from all primary or all autopsy samples failed quality control. WES data were unavailable for two patients at data lock. The final cohort comprised 24 patients.
Patients were assigned study identifiers that were subsequently converted to linked identifiers (CRUKP prefix) to maintain anonymity. Tissue and blood samples were barcoded and tracked in a centralized database overseen by the sponsor (UCL Clinical Trials Centre).
Research autopsy sample procurement
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