SAFIR ABC-10 Precision Medicine Clinical Trial Samples Add to Contact List

Tumour tissue: Where possible, a tumour tissue sample will be obtained from each patient at the time of enrolment into the screening phase of the trial for translational research objectives. This will be a sample harvested prior to the initiation of first line standard of care therapy (this can include archival tissue), or where this is not possible, a pre-treatment biopsy during Cycle 1 of first line standard of care. For patients treated with molecular targeted therapy, where medically feasible, a second biopsy will also be performed in consenting patients at the time of relapse or disease progression to collect a treatment-resistant tumour sample. Blood samples: For patients who participate in the Screening phase and Randomised trial, blood plasma samples are to be collected at the following time points: - At entry to the Molecular Screening Phase of the trial - During the baseline selection period for the Randomised trial - Post-randomisation Visit 4 (Day 64 (±3) post-randomisation) - At disease progression For patients in the control arm who cross-over to receive MTT in 2L, additional plasma samples are to be collected at the following time points: - Cycle 4 Day 1 of cross-over MTT therapy - At disease progression (2L) For patients who participate in the Screening phase only (i.e. those who are not eligible, or decline to participate in the randomised trial), plasma blood samples are to be collected at the following time points: - At entry to the Molecular Screening Phase of the trial. - At Cycle 5 Day 1 of 1L-SoC, or at disease progression if this occurs earlier Whole blood samples will be collected at entry to the Molecular Screening Phase of the trial only.

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Last Updated: 12/18/2023

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