The IC can be written to cover both blood and tumor tissue. Here are a few things to consider as it may be relevant to your study:
What frequency do you expect fresh biopsy will be needed? This could increase risk for testing.
Are the tests approved for this marker? Could result in an IDE or performance evaluation submission in EU Countries.
Is the marker a result of treatment, somatic or germline? How often do you expect inconclusive blood results based on you trial population?
Finally, are you prepared for a companion diagnostic? You can reach out to me privately to discuss things to prepare for if this is the case.
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Sarah Parsons RAC
NorthCoast Consulting
Regulatory Affairs, Diagnostics
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Original Message:
Sent: 13-Oct-2022 16:11
From: Anonymous Member
Subject: ICF for tumor tissue samples
This message was posted by a user wishing to remain anonymous
I have a challenge. For a ph. 1 oncology trial, inclusion requires a blood test positive for a specific biomarker, if the blood test is inconclusive, a tumor tissue sample can be tested (archival or fresh). In the US would we need a separate ICF for the tumor collection, or can we include this in the main ICF? I can't find anything specific here. Thank you!