0. SPONSOR: Roche PROTOCOL: WO29217
FLOWCHART
SPONSOR: Roche PROTOCOL: WO29217
US Region (AP6396, Canada), (AP6397, US)
Version July 2014
(English)

2. Recommended Order of Draw
Only required when there are venous blood draws.
eReq processing instructions will link to trial-specific flowchart.  eReq order of tubes is presented in order of extension, not order of draw.  Sites will be directed to review the proper order of draw by clicking on “Processing Instructions”.
* When using a “butterfly” blood collection set for venipuncture and a coagulation (citrate) tube is the first specimen tube to be drawn, a discard tube should be drawn first. The discard tube must be used to fill the blood collection set tubing’s “dead space” with blood but the discard tube does not need to be completely filled. This important step will ensure proper blood-to-additive ratio. The discard tube should be a non-additive or coagulation tube.*
Source: BD Vacutainer® Order of Draw for Multiple Tube Collections. (Reflects change in CLSI recommended Order of Draw (H3-A5, Vol 23, No 32, )

3. Daily to QLAB Using FedEx
Collection Tubes
Tubes to be sent back
Shipping Temp.
Shipping Frequency
Visit
Tests
Instructions
Draw 8.5ml of blood into the SST tube, filling completely
Invert tube 8-10 times.
Allow to clot for 30 minutes at room temperature.
Within 60 minutes of blood collection, centrifuge at 1500 – 2000g for 15 minutes at 4 degrees Celsius. (same conditions apply if no cool centrifuge is available)
Within 20 minutes of centrifugation, equally aliquot the Serum into each of the 2ml Cryovial storage tubes (labelled Cryovial A, Cryovial B and Cryovial C). There should be approx 1ml of serum in each of the cryovial tubes.
Freeze the 2mL aliquot tubes at -70 degrees Celsius. If not available, store at -20 degrees Celsius then ship within 48 hours of collection.
Ship the 3 cryovial storage tubes on the day of collection, along with the completed requisition form in a frozen condition to Qlab.
Baseline
Pre-dose C5 D1
C8 D1
Pre-dose C14 D1
Pre-dose C18-D1
Study Completion / Early Termination Visit
Unsch/
Retest
Mandatory Serum Samples
Daily to QLAB Using FedEx
Quintiles Ltd.
1600 Terrell Mill Road
Suite 100
Marietta, GA 30067
United States
ATA to Pertuzumab
Pertuzumab Concentration
RCR Serum
Frozen (dry ice)
3 x 2ml Cryovial Storage Tubes
(Approx 1ml Serum into Cryovial A, B & C)
8.5ml SST

4. Container to be sent back
Collection Container
Container to be sent back
Shipping Temp.
Shipping Frequency
Visit
Tests
Instructions
Obtain a tumour block (biopsy material) that contains a representative sample of the tumour.
Fixation of tumor: 10% neutral buffered formalin (equivalent to 4% formaldehyde solution) for 6-72 hours for biopsy specimens.
Tissues should be dehydrated in a series of alcohols, followed by infiltration by melted paraffin held at no more than 60 degrees Celsius.
For pre-treatment core biopsies, at least one core should be sent, which is truly representative of the invasive tumour.
Write patient screening number on the white label for blocks that is attached to the mini-grip bags. Patient screening number: 9 digits.
Put the block in the provided labelled mini-grip bag and write the Block-ID.
Complete the Requisition Form for IED with the necessary information.
Wrap the mini-grip bag with tumour block in the provided shipment material: Either bag or drum as provided by the courier.
Ship the block within 48 hours along with the completed requisition form in an ambient condition (IED).
Ship directly to IEO lab Using Marken
Primary Tumour Block
Screening
Ambient
Stefania Andrighetto Department of Pathology
Istituto Europeo di Oncologia
Via Ripamonti 435
20141 Milan - Italy
60mL Yellow Cap Container
60mL Yellow Cap Container

5. Collection Container
Slides to be sent back
Shipping Temp.
Shipping Frequency
Visit
Tests
Instructions
Obtain a tumour block (biopsy material) that contains a representative sample of the tumour.
Fixation of tumor: 10% neutral buffered formalin (equivalent to 4% formaldehyde solution) for 6-72 hours for biopsy specimens.
Tissues should be dehydrated in a series of alcohols, followed by infiltration by melted paraffin held at no more than 60 degrees Celsius.
Cut 15 slides from the selected tumour block on the microtome. Slide sections should be 4 um thick. Float the sections in a protein-free (e.g. triple distilled) water bath at 40 degrees Celsius.
Mount each section on the coated side of the slides (use only positively charged SUPERFROST Plus glass MICRO SLIDES). Mount only one section per slide and number the slides in the order the sections were cut. Air-dry the slides for at least 2 hours.
Write the patient screening number on the labels on the slide case. Patient screening number: 9 digits
Complete the Requisition Form for the (IED) with the necessary information.
Wrap the slide cases in the provided shipment material: Either bag or drum as provided by the courier.
Ship the fresh cut slides within 48 hours along with the completed requisition form in an ambient condition to (IED).
Ship directly to IEO lab within 48 hours of slides being cut using Marken
Primary Tumour Slides
Screening
Ambient
60mL Yellow Cap Container
Slide Holder
Stefania Andrighetto Department of Pathology
Istituto Europeo di Oncologia
Via Ripamonti 435
20141 Milan - Italy

6. Container to be sent back
Collection Container
Container to be sent back
Shipping Temp.
Shipping Frequency
Visit
Tests
Instructions
Obtain a tumour block (surgical specimen) that contains a representative sample of the tumour.
Fixation of tumor: 10% neutral buffered formalin (equivalent to 4% formaldehyde solution) for 6-72 hours for surgical specimens.
Tissues should be dehydrated in a series of alcohols, followed by infiltration by melted paraffin held at no more than 60 degrees Celsius
For surgical specimens please submit at least 5 mm invasive tumour in the block.
Write patient on the white label for blocks that is attached to the mini-grip bags. Patient enrollment number: 4
Put the block in the provided labelled mini-grip bag.
Wrap the mini-grip bag with tumour block in the provided shipment material: Either bag or drum as provided by the courier
Ship the block within 1 month along with the completed requisition form in an ambient condition to IED
Record processing, storage and shipping in the log provided.
Optional Surgical Tumour Tissue Sample
Monthly to IEO lab Using Marken
Surgery
Ambient
Stefania Andrighetto Department of Pathology
Istituto Europeo di Oncologia
Via Ripamonti 435
20141 Milan - Italy
60mL Yellow Cap Container
60mL Yellow Cap Container

7. Diagnostic Frozen Shipper1.
Select the appropriate protocol visit – specific kit. 4.
Place the SSB & the dry ice (6lb or 3kg) into bottom of shipper. For batch shipping, multiple SSB’s or a cryobox (if supplied) may be placed in one frozen shipper. 2.
COMPLETE the entire requisition form. Collect the sample(s). Centrifuge & transfer to appropriate transfer tube(s), if required. 5.
Place the foam lid on foam – lined shipper. Place the IATA contents card on top of the foam shipper & secure shipper flaps with tape. Attach air waybill to outside of box. Indicate amount of dry ice & shipper information on outside shipper label. 3.
Place tubes into the absorbent tube holder. Place urine tube(s) in plastic bag(s), if applicable. Place tube holder & urine tube(s) & cryobox (if supplied) into the front pouch of the Specimen Shipping Bag (SSB), & place requisition form into the back pouch. Seal bag.
If applicable to your study
Front
Back

8. Diagnostic Ambient Shipper1.
Select the appropriate protocol visit – specific kit & COMPLETE the entire requisition form. 4.
Place the foam liner into the box, as shown in photo. 2.
Collect the tumor & transfer to appropriate transfer container. Place container/slides into the appropriate shipping bag. 5.
Then put Bubble Wrap Bag into Foam Lined Shipper with IATA contents card. Attach air waybill to outside of box. 3.
Place sealed SSB between layers of Gel Wrap
then into Bubble Wrap Bag. Seal bag. Note, two SSBs can be shipped in one bubble wrap envelope per shipper.

9. Study Contacts Quintiles Laboratories Investigator Services
US Toll Free:
8 AM – 8 PM (Eastern Time) Monday – Friday
9 AM – 6 PM (Eastern Time) Saturday
Courier Information
Federal Express
Call to arrange pick up 
Infosario Portal Support
QLAB Sr. Project Coordinator
Denise Sheppard
Direct line:
QLAB Project Manager
David O’Brien
Direct line: