Sir and the management of cancer trial data
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SIR and the Management of Cancer Trial Data. Kate Motohashi Gray Cancer Institute, Northwood, UK. Introduction. BCON Trial Coordinator/ Data Manager since May 2001 Biology background with no experience of databases!. Topics of Discussion. Background to the trial The database

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Sir and the management of cancer trial data

SIR and the Management of Cancer Trial Data

Kate Motohashi

Gray Cancer Institute, Northwood, UK


Introduction

Introduction

  • BCON Trial Coordinator/ Data Manager since May 2001

  • Biology background with no experience of databases!


Topics of discussion

Topics of Discussion

  • Background to the trial

  • The database

  • Retrieval of data

  • Restructuring of the database

  • Some questions


Sir and the management of cancer trial data

A MULTICENTRE RANDOMISED PHASE III TRIAL OF RADIOTHERAPY WITH CARBOGEN AND NICOTINAMIDE IN THE TREATMENT OF LOCALLY ADVANCED BLADDER CANCERTRIALPI: Prof Peter HoskinTRIAL STATISTICIAN Prof Søren BentzenFunded by the Cancer Research UK


Sir and the management of cancer trial data

BCON

  • Bladder cancer 

  • Carbon dioxide 2%

  • Oxygen 98%

  • Nicotinamide


Bladder cancer

Bladder Cancer

  • ~ 4% of all cancers in UK

  • UK incidence 2000: 11 080 (with just over two-thirds men)

  • Peak incidence in 7th decade

  • History of smoking/ exposure to chemicals


Treatment of bladder cancer

Treatment of bladder cancer

  • Surgery

    1.Transurethral resection (TUR)

    2.Total cystectomy

  • Chemotherapy

  • Radiotherapy


Overall 5 year survival after rt

Overall 5 year survival after RT

  • T2, T3 &T4 (muscle invasive): 5-40%


Reasons for rt failure

Reasons for RT failure

  • Intrinsic cell radio-resistance

  • Tumour repopulation during RT

  • Resistant cells due to HYPOXIA

    HYPOXIA: the reduction of the O2

    supply to tissue below physiological levels

    - O2 is crucial for RT success


Aim of bcon trial

Aim of BCON Trial

  • To address the problem of hypoxia by addition of the hypoxia modifying agents, carbogen and nicotinamide


Sir and the management of cancer trial data

  • CARBOGEN: 02 (98%) and C02 (2%)

    Oxygenation of the tumour is increased when cabogen is breathed

  • NICOTINAMIDE: amide of vitamin B3

    Improves perfusion by reducing closure of blood vessels


Phase ii study at mvh

Phase II study at MVH

  • 30 patients received carbogen alone

  • 32 patients received CON

    When compared to historical data significant gains were observed in

  • Local tumour control

  • Disease-free survival

  • Overall survival


Bcon trial

BCON Trial

  • Control arm

    RT alone

  • Experimental arm

    RT plus CON


Endpoints of bcon trial

Endpoints of BCON Trial

  • Tumour response at 6 months

  • Local-failure free survival*

  • Overall disease specific survival

  • Treatment related morbidity*

  • Quality of Life*

    * Requiring ability to store records at different time-points


Target accrual to detect 15 improvement in local control

Target Accrual (to detect 15% improvement in local control)

  • 330 patients over 4 years

  • Recruitment started Nov 2000


Why sir

Why SIR?

  • Good at handling clinical data where patients have multiple visits

  • Compatibility with SPSS

SIR 2000 or SIR 2002?

Old Forms

  • Developed with colour, ‘if’ clauses, width definitions etc

  • Allow double data entry


Design of database

Design of database

  • Case orientated – patient number

  • Schema modelled on Case Report

    Forms

  • Multiple records for morbidity data,

    cystoscopy results and QoL


Sir and the management of cancer trial data

Example of Weeks 1 to 12 symptom recording


Sir and the management of cancer trial data

Record types


Retrieval of data

Retrieval of data

  • Accrual status

  • Dumping to SPSS

  • Follow-up status

  • CRF compliance

  • Reimbursement status

  • Data verification/ error-checking

  • Compliance to Nicotinamide


Sir and the management of cancer trial data

Participating centres


Recruitment cumulative accrual

RecruitmentCumulative accrual


Crf status dec 2003

CRF status (Dec 2003)


Sir and the management of cancer trial data

Old cystoscopy gradings

  • 0 no tumour

  • 1 > 50% reduction

  • 2 < 50% reduction

  • 3 progression

  • 4 recurrence after complete remission

  • 5 new superficial cancer


New cystoscopy gradings

New cystoscopy gradings

  • 0 no tumour

  • 1 superficial

  • 2 muscle invasive


Cystoscopy results in database

Cystoscopy results in database


1 missing values

1. Missing Values

  • Up to three values can be specified which are missing values for the variable. Missing values are excluded from statistical procedures and functions.

    BCON Database Missing Values

  • BLANK = not available (ever)

  • ‘9’/ ‘99’/ ‘999’ etc = not available (yet)


Sir and the management of cancer trial data

RETRIEVAL

.PROCESS CASES ALL

. PROCESS REC NEWCYST

. GET VARS TUMSTATE

. IFTHEN (EXISTS (TUMSTATE) EQ 0) WRITE PATNO

. ENDIF

. END PROCESS REC

.END PROCESS CASE

END RETRIEVAL

This retrieves field with missing value but doesn’t distinguish between different categories of missing values


2 wild card searches

2. Wild card searches

  • Using search mode in forms and % for unknown characters

  • E.g. ‘F%W%’

  • Can it be done with PQL?


3 editing log

3. Editing Log

  • Journalling – logs changes to the database

  • Is it possible to create a log where person editing data is prompted to give a reason for the change?


Acknowledgements

Acknowledgements

  • Prof Søren Bentzen

  • Prof Peter Hoskin

  • Dr Francesca Buffa

  • Trial centre contacts


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