PROTOCOL NRG-LU004 – STUDY REOPENED TO ACCRUAL WITH PROTOCOL AMENDMENT 1

The NCI Central Institutional Review Board (CIRB) has approved this protocol amendment. Protocol documents can be obtained from the CIRB tab of the CTSU website.


Due to the specimen logistics update, documentation of IRB approval of the amendment must be submitted to the CTSU Regulatory Office prior to enrolling participants.

For details, please review the summary of changes.


Note:
The following administrative correction will be made to Section 10.5.3 at the next amendment. Sites should adhere to Section 10.4 for this collection.



SECTION

CHANGE

10.5.3 collection table

For the Pre-Treatment, Day 15, Day 30 and 3 Month Post Treatment blood draws into Streck tubes, “9mL” will be corrected to “10mL”.

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