Tissue Banks – Why Bother?!?

Dr Nik Zeps

Radiation Oncology

Sir Charles Gairdner Hospital

Why do tissue banking?

Tissue Bank-history

• Done by interested individuals• Unregulated• None or poor consent• No SOPs• None or poor databases• Wide variation in storage conditions• Poor assessment of use• Quality?

Australia•‘Discovered” in 1688 by William Dampier

•Not colonised until 1788-Capt James Cook

•WA not until 1829

•9 Australian Parliaments (6 states, 2 territories and 1 federal)

•Popn•1914-3 million•2004- 20 million

RPH

Mount

KEMH

Joondalup

SJOG

SCGH

SJOG

Fremantle

10km

•Carries out

–Consent

–Collection

–Processing

–Storage

–Data linkage (WAGER)

•AOCS (ovarian)-1000 (147)

•RADAR (prostate) -200

•IAB (Prostate)-150

•TARGIT (Breast)-150

•Cancer Fatigue 100

•Locally Advanced BC

•Colorectal cancer -general

•Breast Cancer-general

•TMAs (3000)

WARTN

Consent form F O R M 7 3 0 .8 U R N :

W A R E S E A R C H T I S S U E N E T W O R K C O N S E N T F O R M

S U R N A M E : F O R E N A M E : S E X :

D O B :

C o n se n t fo r t is s u e /b lo od ta k in g a n d ti s su e /b lo o d b a n k in g fo r c l in ic a l r e s e a r c h I , _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ o f_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

h a v e r e a d t h e I n fo r m a t io n B r o c h u r e e n t i t le d “ W A R E S E A R C H T I S S U E N E T W O R K ” . ( D o c to r o r h e a l t h p r o fe s s io n a l ) … … … … … … … … … … … … .. h a s e x p la i n e d to m e a n d I u n d e r sta n d th e c o n s e q u e n c e s i n v o lv e d in m y v o l u n ta r y d o n a t io n o f t i s s u e a n d /o r b lo o d fo r th e W A R e s e a r c h T i s s u e N e tw o r k . I h a v e h a d a n o p p o r t u n it y t o a s k q u e s t io n s a n d a m s a t i sf ie d w it h t h e a n s w e r s g iv e n

I n m a k in g m y d o n a t io n , I u n d e r s ta n d a n d a g r e e th a t :

1 ) th e t i s s u e /b lo o d (w h ic h i n t h i s c o n s e n t fo r m , i n c l u d e s i t s c o n s t i tu e n t s a n d a n y c e l l l in e s d e r i v e d f ro m

th e t i s s u e /b lo o d ) w i l l b e u s e d in r e la t io n to ( W R IT E I N P R O J E C T N A M E ) , 2 ) s a m p le s o f a n y t i s s u e /b lo o d o r d e r iv e d c e l l l in e / s h e ld i n a b a n k w i l l b e d i sc a rd e d u p o n m y w r i t te n

r e q u e st to t h e W A R e se a r c h T i s s u e N e tw o r k P r o je c t M a n a g e r , 3 ) th e r e s u l t s o f r e se a r c h s t u d ie s a re d e e m e d e x p e r i m e n ta l a n d n o t fo r d ia g n o st ic p u r p o se s a n d t h e r e fo re

n o t i n te n d e d to b e p a s s e d b a c k to m e o r m y i m m e d ia te fa m i l y , 4 ) I w is h / d o n o t w ish to b e i n fo r m e d o f i m p o r ta n t g e n e r a l r e s u l t s a n d t h e p r o g re s s o f a n y st u d y

th r o u g h a n e w sle t te r w h ic h w i l l c o n ta in i n fo r m a t io n a b o u t t h e s e st u d ie s i n a fo r m t h a t w i l l n o t a l lo w in d i v id u a l s to b e id e n t i f ie d ,

5 ) I c a n r e q u e st to k n o w m o r e sp e c i fic d e ta i l s o f a n y st u d ie s th a t u s e d m y sa m p le s a t a n y t i m e b y c o n ta c t i n g t h e W A R T N ,

6 ) R e se a r c h r e s u l t s , a n d th e fa c t t h a t I h a v e m a d e t h i s d o n a t io n , w i l l n o t b e r e v e a le d to a n y 3 rd p a r t y n o t d i r e c t ly p a r t o f m e d ic a l r e se a r c h w i t h o u t m y w r i t te n c o n s e n t , e x c e p t u n d e r s u b p o e n a ,

7 ) T h e W A R e s e a r c h T i s s u e N e tw o r k w i l l n o t b e l ia b le fo r a n y lo s s o f o r d a m a g e t o , th e t i s s u e /b lo o d u s e d in a c c o r d a n c e w i t h t h i s fo r m ,

8 ) I w i l l n o t b e n e f i t f i n a n c ia l ly i f t h i s r e se a r c h le a d s to d e v e lo p m e n t o f a n e w t r e a tm e n t o r m e d ic a l te st , 9 ) sto r a g e o f a n d a c c e s s to m y t i s s u e /b lo o d w i l l b e m a n a g e d b y a n A d v i so r y C o m m it te e a n d o n l y

r e le a s e d w h e re th e r e se a r c h p r o p o sa l h a s b e e n a p p r o v e d b y a H u m a n R e s e a rc h E th ic s C o m m it te e , 1 0 ) I u n d e r sta n d t h a t in t e rn a t io n a l r e se a rc h c o l la b o r a t io n u si n g m y t i s s u e /b lo o d w i l l o n l y ta k e p la c e

w h e r e r e se a r c h e r s a b id e b y e q u a l o r m o r e st r i n g e n t r e g u la t io n s o f p r i v a c y a n d e th ic s a s t h o se i n A u st ra l ia , a s a s s e s s e d b y a H u m a n R e s e a rc h E th ic s C o m m it te e

1 1 ) I g iv e p e r m i s s io n to a c c e s s h e a l t h i n fo r m a t io n a b o u t m e re la te d to th e r e se a r c h a re a d e fi n e d i n p o i n t 1 a b o v e , s u c h a s i s k e p t in a m e d ic a l r e c o r d o r b y t h e W A D e p a r t m e n t o f H e a l th , to a s si st m e d ic a l r e se a rc h o n l y w h e re t h e r e s e a r c h p ro p o s a l h a s b e e n a p p r o v e d b y a H u m a n R e se a rc h E th ic s C o m m it te e .

I D o

D o N o t

c o n s e n t to th e s to ra g e a n d u se o f m y t i s s u e a n d /o r b lo o d (d e le te a s a p p r o p r ia t e ) fo r b io c h e m ic a l a n d g e n e t ic b a s e d m e d ic a l r e se a rc h . … … … … … … … … … … … … … … ..… … … … … … … .… … … … N a m e o f P a t ie n t S ign a tu re o f P a ti e n t D a te … … … … … … … … … … … … … … … … … … … … … . … … … … . N a m e o f W itn e ss W itn e ss to S ig n a tu re D a te … … … … … … … … … . … … … … … … … … … … .… .. … … … .… N a m e o f D o c to r S ign a tu re o f D o c to r D a te

WA

RE

SE

AR

CH

TIS

SU

E N

ET

WO

RK

CO

NS

EN

T F

OR

M

Sir

Ch

arle

s G

aird

ner

Hos

pita

l – H

osp

ital A

ven

ue,

NE

DLA

ND

S W

A 6

00

9 T

el +

61

8 9

346

33

33

Fax

+61

8 9

346

2534

Management

North Metropolitan Area Health Service

Government of WA

Cancer Clinical Services Unit

WARTNWARTN Advisory

Committee

Radiation Oncology

Project Driven Collection

• Australian Ovarian Cancer Study• TARGIT: TARGeted Intraoperative radioTherapy for Early Breast Cancer

• RADAR: trial investigating the effect on PSA and survival of patients with localized prostate cancer by using different durations of androgen deprivation combined with radiation treatment

– TGF-1 and MMPs– h2ax– IL12

• Locally Advanced Breast Cancer-neoadjuvant– PhD project on apoptosis and metabolism

• Colorectal– methylation

TMAs•Colorectal TMA 17 blocks representing 1050 cases

– Burnham San Diego, Alabama (Grizzle), Erasmus Rotterdam, NUH singapore

• Ovarian cancer: 3 blocks representing 221 cases– Med solutions

•Breast Cancer 5 blocks representing 600 cases – Westmead, Flinders, WAIMR

•Gastric Cancer 2 blocks representing 120 cases – Peter Mac, NUH singapore

•Han Qian Feng, Anne-Marie Shearwood, Zhao Wen Ying, Nik Zeps, David Joseph, Barry Iacopetta, Arun Dharmarajan (2005) sFRP-4 and β-catenin in Colorectal Carcinoma. Cancer Lett. 2006 Jan 8;231(1):129-37. •Chai M, Zeps N, Joseph D, Goldblatt J, Harvey J, Charles A, Iacopetta B (2004) Loss of expression of hMLH1 and hMSH2 mismatch repair enzymes in a population-based series of colorectal cancers. Clinical Gastroenterology and Hepatology 2004 Nov;2(11):1017-25

What issues remain?

• Uncertainty– Cooperation of Stakeholders– Demand

• Do researchers know what is possible?

– Trust– Regulation– Money

Proposal: Routine Pathology run tissue banking

• Pros– All samples routinely come through them– Are SOP driven– Trained staff– Appropriate facilities– Legislated to keep samples for QA

• Cons– Performance management means no money for

biobanking• Research not part of the new culture

– No consent– Academic pathology demise

Pathwest Research Services

• Prospective bio-specimen collection

• Specialised processing of samples

• Storage services of bio-specimens

• Ethics services/consultation

• Management of and Access to Associated health information

Workflows

Steps involved in tissue banking Pathology External AgencySample collection

Identifying procedure date and time 1 min. 5 min.Delivery or pick-up of samples 0 10 min.

Sample processing Cut up 2 min. 2 min.Processing and embedding 1 min. 10 minMicrotome cutting 2 min. 10 minH&E Staining 1 min. 5 minPathology review 5 min. 30 minStorage 1 min. 15 min

Information collection Requesting pathology report 1 min. 20 min

Total amount of time taken 14 min. 107 min

Time taken to obtain paraffin embedded block

Patient identification

Pros Cons

Pathology

One step process for identifing procedure date and time, as theatre lists are available electronically. Liaising of pathology laboratory with theatre is required.

External Agency

Multiple step process, as staff is liaising with theatre, pathology and surgeon. Theatre lists are not available electronically and extra time is taken for organising sample pick-up and delivery.

Consent

• Treating Dr obtains a consent to contact– Tissue Bank staff obtain consent

• ‘opt out’ consent– All pts for elective surgery have tissue banked

unless state no

• Blood or health information still require ‘opt in’ consent– Likely to be required for time to come

Interim plan

• Collect only for Projects

• Full cost recovery

• Community owned– Benefit sharing

• Transparent Governance

• New approaches to consent and community engagement

Other WA initiatives

• WA DNA Bank– To operate out of Pathwest

• Incorporate all existing DNA banks– WARTN, Busselton, CVD, Diabetes, mesothelioma,

melanoma, Joondalup Health Survey, Raine, Sleep apnoea, AMD

• WA Genetic Epidemiology Resource– All existing clinical databases– WA Data Linkage Project

The Future

• Specimen collection under routine path services

• Standardise consent, SOPs etc• Integrate with all other specimen/health info

groups in Perth• Promote cooperation amongst researchers• Engage with community to maximise

outcomes.