EORTC Trial 10041 (BIG 3-04) - MINDACT

Centre facilities Questionnaire
(to be completed by the responsible Oncologist/Surgeon after discussion with the Pathologist and Surgeon/Oncologist)

The MINDACT study is a very exciting trial however it is also avant-garde and therefore requires special expertise and facilities to insure that it runs smoothly. For the MINDACT study processing of a frozen tumour sample is mandatory for inclusion. This sample would have to be stored at your Institute until a courier comes to collect it. We understand that this involves additional work and that some centres might not be able to participate for logistical reasons. This questionnaire is intended to learn more about your local facilities and practices to help us evaluate whether your centre meets the requirements to participate in the MINDACT trial.

Some of these questions may seem repetitive or may ask questions that you have responded to in the past however, please answer all questions as we need this information to better identify appropriate centres.

Centre facilities Questionnaire
Name of Investigator
Investigator function in the department
Institution
EORTC Institution number (if applicable)
Type of institution e.g. University, Hospital, Institution or Data centre
Department
Address
City, Zip code
Country
Phone and Fax Number
E-mail address
1. Do you belong to a Cooperative Cancer Research Group?
  Yes, national group, please specify
  Yes, international group, please specify
  No
2. If you belong to several Cancer Groups please specify through which group/entity you would like to participate in the trial?
  I will participate in MINDACT through
3. Please confirm that you have the facilities listed below that are a prerequisite for participation in the MINDACT trial. (Please tick as appropriate)
  Centre works according to Good Clinical Practice / ICH-GCP
  Team has a proven track record of performing phase III clinical trials
  Centre has local infrastructure/personnel available for the management of clinical trials eg
    Research nurse
    Data manager
    Lab staff for tissue handling, including giving samples to courier
    Pharmacist used to participating in clinical trials
  Team has Internet access and the necessary computer literate personnel to fill in
CRFs online? (i.e. use Remote Data Capture)
4. The MINDACT trial will require the involvement of a multidisciplinary team. Please confirm that you have discussed the trial with the surgeon, pathologist and oncologist and that they are also keen to participate.
  Yes
  No
5.The first informed consent must be signed before surgery, who will be responsible for this in your Institute?
  Surgeon
  Research nurse
  Data manager
  Other, please specify
6. How long does it take for your local pathology department to determine lymph node status?
  Maximum days.
7. Does your institute perform a sentinel lymph node procedure before operating to remove the primary tumour, i.e. you would know lymph node status before removing tumour?
  Yes
  No
8. Does your institute perform an intra-operative frozen section sentinel node procedure to predict if a patient is node negative or positive before local pathology confirmation of node status?
  Routinely
  Experimentally/ not yet validated
  Never
9. Do you have a track record in translational research involving the freezing and storage of tissue e.g. participated in the EORTC 10994-p53 trial?
  Yes I have a track record in freezing and storing tissue
  No I do not have a track record in freezing and storing tissue
10. Do you freeze breast tumour samples in your Institute?
  Routinely
  As part of research program(s) only
  Never, but we could do it
  Never and we could not do it
11. Where do you freeze the samples?
  In the operating room
  In the pathology department
  Other, please specify
12. Do you freeze the samples?
  Immediately
  After a few minutes of delay
  After a longer delay
13. Can you freeze tumour samples?
  Directly in liquid nitrogen (snap freeze)
  In an isopentane bath in liquid nitrogen (OCT procedure)
14. Do you have access to a -80°C freezer in which to store the blood and tumour samples?
  Yes
  No
General comments

 

EORTC BREAST CANCER GROUP
INTEREST FORM

In principle I will be interested to participate in the above study
How many new node negative breast cancer cases do you see per year? patients per year
How many patients that would fulfill the eligibility criteria, would you expect to enroll per year? patients per year
Do you have any competitive trials in the same indication?
If yes, when will enrollment in competing trials expect to end?
Are there any practical reasons, why you may find it difficult to enroll patients into this trial? If yes, please specify:
I understand that this procedure is not definitively binding me/my center to the study but I realize that preliminary interest will be used to evaluate the potential accrual of the proposed trial and set up the study infrastructure.

If you would like to keep a copy of this information please print before submitting

Only to be completed by EORTC breast group centers - NCCs and NCGs

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