Mammo-50 CRF Queries
How frequently do Mammo-50 patient booklets have to be administered?
These should be given to patients whenever they attend for a scheduled mammogram. Therefore
the patients in the standard arm of the trial will be completing these annually, whereas other
patients will be required to complete them every two or three years depending on their allocated
treatment.
Digital Mammogram Form- CRF 4A- Our radiographer hasn’t had training on how to get the VAS
and ACR scores, are there any guidelines that exist to assist in getting these scores?
There are a number of online guides to breast density analysis including from the ACR themselves.
The VAS is easier as there is not the difficulty of assigning to a specific category and any breast
radiologist should be able to do this. Minor differences in interpretation /assessment will not be
important as only broad general trends will be looked for.
Digital Mammogram Form- CRF 4A- In relation to Question 4.2.2 The BIRADS 5th Edition has been
issued and uses A-D. The old version used 1-4. Do we simply substitute A with 1, etc?
Yes, please substitute A with 1, B with 2 and so on.
QOL Booklet- How is page 3 to be completed of the Participant QOL booklet regarding the
interview questions?
There is no need to carry out an interview as this is an error in the booklet. Please just ask the
participant to add their highest ranked concern to this page. We will be amending this page of the
booklet when we submit our next amendment, which will be autumn 2014.
Baseline Form- CRF3- When calculating the NPI, does tumour size mean invasive tumour only or
does it include DCIS?
Please use the Invasive tumour only.
Baseline Form- CRF3- Page 5, Section 2.This patient had DCIS only and therefore had no Invasive
Tumour Characteristics. I am presuming that I leave this section completely blank?
It is fine that you leave this section blank and just complete the section relating to DCIS only.
Baseline Form- CRF3- Page 6, Section 4, Excision Status. I am reporting on the first surgical
procedure for this patient, which was a wide local excision (She then went on to have another
WLE and then a Mastectomy with an immediate reconstruction)
This is correct please just report on the first surgical procedure.
Baseline Form- CRF3- Page 6, Section 4. The first surgical procedure this lady had was an
incomplete excision of the radial (i.e. medial/inferior) margins hence she went on to have further
surgery. However, there is no box to tick for incomplete excision in Question 2 “Distance from the
closest radial margin” Do I just leave this blank as I have ticked “no” to Question 1 “Excision
margins clear”
This is confusing as the NICE guidelines say that margins are not clear if there is less than 2mm of
disease free tissue on excision so in some circumstances it will be possible to tick “No” in
Question 1 and still tick one of the boxes in the “Distance from closest radial margin” Question 2.
After speaking to the Chief Investigator she recommends that you say “No” to excisions margins
clear and then “<1mm” for distance from closest radial margin.
Baseline Form- CRF3- Page 8, Question 3.8.4 & 5. Currently there are only three boxes for radiation
dose, I will need 4 because the dose is 40.05
Where appropriate please round up the radiotherapy dose to one decimal place.
Baseline Form- CRF3-Page 6, Question 4.2. Please can you advise how the radial margins are
worked out?
Radial margins can be worked out using the Medial score, Lateral score, Superior and Inferior score.
If you have more than one of these scores please use whichever of these is the smallest distance
when answering this question.
You ask for type of disease, DCIS, Invasive or DCIS/Invasive in the pathology baseline forms.
I’m currently doing the forms for a newly recruited patient this is her histology report:
It is 20 mm in maximum dimension with adjacent high grade comedo DCIS extending the area
involved to 25 mm. Do we say that she had invasive/DCIS disease? Also when it asks for the DCIS
size there is no specific size of the DCIS just that it extends the maximum dimensions to 25mm.
How would we record this on the CRF?
Please class this tumour as DCIS and Invasive. Please record the DCIS part of the tumour is 5mm and
the Invasive part as 20mm. Then the whole tumour size 25mm.
Please could you tell me who should print and sign their name on the bottom of the eligibility
form and the randomising form for Mammo50 as unsure if 'investigator' means just the PI or other
members of the investigation team such as the clinical trials co-ordinator and data manager?
Eligibility Form- So long as the person signing the eligibility form has code 4 (review eligibility and
sign participant eligibility form) assigned to them on the delegation log they are fine to sign this.
Randomisation Form- On the randomisation form so long as the person has code 6 (CRF completion,
correction and return and participant questionnaire distribution and collection) assigned to them
they can complete this form.
With regards to the Observational Cohort could I check if the Patient Questionnaire Booklet and
the QOL (if applicable) should be administered at baseline and the subsequent visits – same as the
Main Study?
Please only administer the Cohort Questionnaire Booklet at baseline only and not subsequent visits.
There is a printing error on the front of this booklet which includes the subsequent visits by mistake.
The QOL questionnaires need to be completed up to year 10 as stated on the front of the
questionnaire booklet this is the same for both Main and Cohort participants.
I have recently done the 1 year f/u for the above patient. She was relatively well although she
mentioned a bout of vomiting and stomach upset following a change in her diabetes medication.
My query is whether you want this reported as an AE or not? I can’t see anything in the protocol
regarding AEs but I wanted to double check with yourselves.
We don’t have safety reporting on Mammo-50 so you won’t need to record this anywhere.
For page 5 of the base line form where it asks for DCIS size and invasive tumour size, what is the
approach for pts who have a WLE followed by mastectomy? In the case of pt ID# 351, EB both
surgeries gave positive results with defined sizes of DCIS and tumour. Do you add the size of
the DCIS / tumour together from both surgeries, or do you give just the measurements from
the initial surgery?
Please can you refer to the initial surgery measurements.
On page 6 of the baseline form, for the excision margin where the pt has had a WLE followed by a
mastectomy, do you take this from the first Rx, i.e. the WLE or the second Rx the mastectomy?
Please can you refer to the margins taken in the WLE.
I am currently completing CRF 3 Page 6. Receptor status, on-slide positive control material, please
can you explain what this is as I'm unsure.
After to speaking to the Pathologist who is part of the TMG (Sarah Pinder) and the Chief Investigator
Janet Dunn. This is the normal breast tissue adjacent, which should be positive and which
pathologists use as a quality control measure. However this doesn't need to be on the CRF.
I understand that you have requested the QoL questionnaires should not be given at this visit but
sent to patients on the anniversary of their recruitment? Why is this?
We have asked for QOL questionnaires to be given on the randomisation or registration anniversary
because of trying to collect information on how the patient feels at a different time point to when
they are completing their participant questionnaire, which is given at each mammogram.
Digital Mammography Form- VAS Breast density of opposite breast – we do not complete this
measurement and therefore these have been left blank by our Radiologist. Could you please
advise how best to complete this form if the information is missing.
The VAS value is the average of MLO (mediolateral oblique) and CC (craniocaudal) value for the
diagram. The VAS is easier as there are isn’t the difficulty of assigning to a specific category. Minor
differences in interpretation /assessment will not be important as only broad general trends will be
looked for.
We are suggesting that these forms are completed in batches as this may be easier for the
radiologist as we’re aware that some of the information we are requesting isn’t reported as
standard.
I am completing a baseline CRF for a Patient who has had a Neo-adjuvant Chemo. Her original
histology on core biopsy showed a Grade 2 Ductal Carcinoma with low grade DCIS, however her
surgical histology showed no residual invasive tumour or DCIS but LCIS present in cavity biopsy.
Can you inform how I complete the pathology section of form 3 page 5? Do I record the results of
just the surgical histology?
Both Co Chief Investigators have advised that path part of Baseline CRF is completed with Core
biopsy report. This information has been forwarded to Tania Allen.
We are aware that the patients consent not to attend these but just in case they decide to or if
they attend a symptomatic clinic and have a mammogram what would we need to do? Is there a
CRF? Do they have to be withdrawn?
If a participant attends for a mammogram within the National Screening Programme we wouldn’t
expect you to withdraw the participant from the Mammo-50 trial.
If this happens, which it is very possible that it will. Please complete CRF 10 (Protocol Deviation
Form) and then when you are due to complete CRF 5A (Annual Follow-up Form) for the participant
please also note this in section 5.1.5 Has the participant had a mammogram in the last 12 months?
You would tick Yes followed by other and provide the details.