Persephone
Newsletter Issue 35
March 2015
Duration of Trastuzumab with chemotherapy in patients with early stage
breast cancer: Six months versus Twelve
Top 20 recruiters for 2015 so far…
Thank You to all these Sites!
Easter closure
...from the PERSEPHONE team
Randomisation
The randomisation lines will be closed during the Bank Holidays
i.e. 3rd to 6th April, 4th and 25th of May 2014. The Warwick trials
office will be closed during this time so please contact
Cambridge (see overleaf) with any urgent matters.
Blood sample dispatch
Please do not send any bloods the day before the Bank
Holidays. You are advised to please store blood samples in your
fridge and send it the following Tuesday.
SAEs
Please fax SAEs or incident reports to the usual Cambridge
Trials Office fax number provided on the SAE Fax Cover Sheet.
Latest recruitment news!
Current recruitment: 3814pts.
(27.03.15)
Recruitment has really kick-started this year
with 47 patients randomised in January and a
fantastic 57 in February !
A HUGE thank you to all clinical investigators
and their research teams who are contributing,
not just in relation to recruitment, but also for
taking the time to screen and approach eligible
patients.
The trial needs +53 patients a month to finish by
the end of June 2015!
Russells Hall Hospital
7
Queen Elizabeth Hospital (Birmingham)
5
Addenbrooke's Hospital
4
Yeovil District Hospital
4
Wexham Park Hospital
4
Charing Cross Hospital
4
Raigmore Hospital
4
Royal Sussex County Hospital
4
James Paget Hospital
4
Darent Valley Hospital
3
Peterborough City Hospital
3
East Surrey Hospital
3
City Hospital
3
Royal Hampshire County Hospital
3
Ipswich Hospital
3
Northampton General Hospital
2
Queen Alexandra Hospital
2
Luton and Dunstable Hospital
2
Queen Elizabeth Hospital (King's Lynn)
2
Aberdeen Royal Infirmary
2
Blood and Tissue sample collection
ALL sites with outstanding blood
samples were contacted a couple
of months ago. Outstanding blood
samples should be sent to
Cambridge ASAP. Please contact
Cambridge if you need an
updated list.
REMEMBER, the sooner you sample patients, the
easier it is. We recommend sampling your patient
at randomisation.
Tumour blocks requests will be
sent out this month.
If YOU are the nominated person
in charge of the collection at your
Site, the please contact Cambridge
for the list of blocks to provide.
Thank you!
SUSAR
PERSEPHONE EMAIL ACCOUNT REMINDER
From 4th March, the Persephone trial e-mail account
became fully functional. Please use this e-mail address
for all trial related queries intended for Warwick staff:
persephone@warwick.ac.uk
Please do not email Shrushma, Donna, Lisa or Peter
directly but rather send your email to the address above
and mark it for the attention of either:
Shrushma- eligibility, randomisation changes, violations
and
withdrawals,
recruitment
issues,
regulatory
documents, pharmacy issues, H@H and any other ad-hoc
queries.
Donna– Site maintenance documents (Site Signature and
Delegation
Logs,
CVs,
reg
forms,
pharmacy
docs), patient hospital transfers, PI change related
documents, ethnicity data.
Lisa & Peter- any queries related to CRF, i.e. CRFs
outstanding, guidance on completing, time-points and
expectedness, confirmation of CRFs returned, request for
materials.
Please be aware that this e-mail account will not be
checked during the Bank Holiday closures however, the
Persephone team will endeavour to answer your queries
on the first Tuesday back.
Translational sub-studies contacts
Please remember your contact for the TransPERSEPHONE (Tissue block collection) and Trans–
PERSESONE—SNPs (blood collection) is Anne-Laure
Vallier at Cambridge Clinical Trials Unit. Contact details
are provided below.
We have reported a new SUSAR to the MHRA: a patient
was diagnosed with close-angle glaucoma whilst on trial
treatment, which the site PI thought was possibly related
to trial treatment (Herceptin). We are awaiting follow-up
data from the patient’s ophthalmology appointment.
Ethnicity data
Thank you to all Sites for your prompt response with
returning the ethnicity data. We have received a huge
amount of data. Remember, it’s only the ethnicity page
that patients need to complete if they were randomised
prior to staring Trastuzumab.
Recap on dealing with data queries
The Data Management team are busy querying CRFs and
you may have already received batches of forms for querying. We would appreciate if these queries were returned
as soon as possible and preferably within 2 weeks of receipt. Where changes have been made to CRFs please
remember to:
1. Clearly amend the CRF and/or Data Clarification
Form (DCF) sent to you from the Persephone Trial
Office.
2. Initial and date next to all changes made.
3. Retain a photocopy of the amended CRF and/or DCF
in Section 11.9 of the Investigator Site File.
4. Send the updated CRF and/or DCF to the Persephone Trial Office.
Note: Where a DCF has been sent with a CRF, BOTH
documents must be completed with the correct matching
information, signed and dated and returned to the
Persephone Trial Office.
PERSEPHONE team
Trial Coordination (Warwick)
Mrs Shrushma Loi
Persephone@warwick.ac.uk
Phone: 0247 615 0492
Clinical Trial Administration (Warwick)
Miss Donna Howe
Persephone@warwick.ac.uk
Phone: 0247 615 0600
Data Management (Warwick)
Miss Lisa Poulton
Persephone@warwick.ac.uk
Phone: 0247 615 1665
Mr Peter Bell
Mr John Carey
Translational Studies (Cambridge)
Mrs Anne-Laure Vallier
anne-laure.vallier@addenbrookes.nhs.uk
Phone: 01223 348086
Pharmacovigilance
(Cambridge)
Ms Louise.Grybowicz
Louise.grybowicz@addenbrookes.nhs.uk
Phone: 01223 348447
&
Pharmacy
The views and opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health