Sub Studies FAQs

 

Saliva- Germline DNA Analysis
a. What should I do if the trial label is missing from the kit? 

Please label the saliva kit with the patient trial number using a pen. If the barcode label is also missing the sample can still be sent but please make a note on the saliva CRF.

 

b. Who is eligible to donate saliva sample? 

Saliva sample can be collected from all patients (all arms) who have joined STAMPEDE since November 2011.

 

c. Who in the trial team can take consent? 

Trained research personnel who are delegated to take consent as listed on the delegation log.

 

d. How can I find out if a sample was collected for a patient? 

Sites are expected to keep track of what samples have been collected for patients in the STAMPEDE sub studies. Please ensure to keep a copy of the saliva form, use the accountability log found in the Sample collection and handling manual or on the STAMPEDE website to help with sample tracking.

 

e. When can saliva samples be collected?

Saliva can be taken at any time point and only one saliva sample is required per patient.

 

f. Will patients be notified of their results?   

The only results reported back to patients will be those which have known medical implications and for which testing would be available under standard NHS genetic testing guidelines.

The results of this research analysis may not be available immediately and does not replace any genetic screening that your doctor may recommend as part of standard clinical care.

 

 

Sequential Blood Collection- Circulating Tumour DNA
g. Who is eligible to participate in circulating tumour DNA (ctDNA) sub study?  

This sub-study is now being conducted only in Arms A and J patients.

Informed consent is provided on the additional research consent form, obtained after participants have reviewed the accompanying additional research PIS.

 

h. Who should be reconsented?

Patients should be re-consented to v3.0 (most recent version) of the additional research consent form if:

  • Patient is at pre-progression stage as they may potentially provide blood samples at additional sampling time points (see sample collection and handling manual)
  • Any patient who would like to alter their consent to permit feedback of results of clinically significant genetic tests which may be available through the analysis of saliva, blood or FFPE tumour block.

 

i. Why are patients being re-consented? 

To reflect changes in sampling collection time points as per protocol v16.0 onwards and the opportunity for patients to receive feedback of clinically significant genetic results.

 

j. Can we use another blood tube if we run out of Streck tubes? 

No, only the provided streck tubes are suitable for analysis for the ctDNA sub study. Please Do Not use other blood collection tubes. If you need additional kits please email: mrcctu.stampede@ucl.ac.uk.

 

k. Can we collect blood samples before the patient is randomised? 

No, for ctDNA sub study only collect blood samples when the patient has been randomised and has a trial ID. This is because the laboratory is unable to process samples if there is no trial ID.

 

l. What should be done if a patient visit time point is missed?

If a sampling time point is missed please complete the blood CRF to indicate that samples were not collected/missed and send a copy to MRC CTU at UCL.

 

m. Can we collect the next sampling time point if the previous time point was missed? 

Yes, please continue to collect bloods at the correct sampling time point schedule even if a previous sample was missed.

 

n. Will patients be notified of their results?               

The only results reported back to patients will be those which have known medical implications and for which testing would be available under standard NHS genetic testing guidelines.

The results of this research analysis may not be available immediately and does not replace any genetic screening that your doctor may recommend as part of standard clinical care.

 

 

FFPE Archival Tumour Block Collection
o. Where do I send the tissue CRFs? 

One copy will go alongside the blocks to the designated biobank and another copy will be sent to the MRC CTU at UCL.

 

p. Is a pathology report required to be sent with tumour blocks?  

Yes, please send an anonymised copy of the pathology report along with the tumour blocks.

 

q. Will the tumour blocks be sent back to us post analysis? 

Every effort will be made to preserve tissue. We will return any usable tissue back to sites once our analysis is complete.

 

r. How many blocks should be sent per patient? 

All of them, if this is not possible, send us the block with highest tumour content.

 

s. How many slides should be sent per patient? 

A maximum of 1 representative H&E slide per block should be sent.

 

t. How can I know if a patient has given appropriate consent to this allow for this collection? 

Refer to page 17 of the sample handling manual, available on the STAMPEDE website, where there is a table on how to check for appropriate consent.

 

u. How can I claim for reimbursement for any tumour blocks sent?

You can submit an invoice by email to mrcctu.stampede@ucl.ac.uk referencing the STAMPEDE trial IDs of the blocks you are invoicing for.

 

Have another question or looking for more information? why not check out the STAMPEDE Training Suite for the training slides detailing information on STAMPEDE.

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