1. Registration as a potential participant

1.1.  Participants may register themselves on line or ask their research/specialist nurses or other members of the multidisciplinary melanoma teams (MDTs) to initiate the process. This latter approach is preferred, but MyMelanoma feels that individuals should be able to choose to participate independently of their medical staff. The online system will be accessed via the MyMelanoma web site and will be based in the REDCap system.

1.2.  Information for potential participants will be provided on line as text to be read on line and PDFs to be down loaded by participants and members of the MDT.

1.3.  The web site will include text of “Frequently Asked Questions”

1.4.  Potential participants will also be able to ask questions via email or telephone.

1.5.  The registration process for newly diagnosed patients will require the participant or the member of the MDT to enter basic eligibility factors such as AJCC stage, age and preferred mode and details of contact eg email, post or telephone. For those diagnosed previously the medical details should be available from PHE

1.6.  Registration will trigger an e-mail to the MyMelanoma team who must contact the potential participant within 48 hours for routes to entry requiring samples to be obtained or if requested by the participant. Striaght forward recruitments will be managed by the automatic e-mail system.. The purpose of contact will be

1.6.1.     to confirm eligibility

1.6.2.     to answer any queries that the potential participant may have

1.6.3.     to discuss practical issues eg the dispatch of blood test and stool collection kits

1.6.4.     to establish the preferred method of data collection. It will be possible for example to complete questionnaires using the telephone if that is needed by the participant

2. Consenting

2.1.  The consenting process will be carried out predominantly on line by the participant, or in conjunction members of the MDT. 

2.2.  The consenting process will be very specific and will include tests of understanding eg asking the participants to indicate their understanding of what they have agreed.

2.3.  On receipt of an electronic consent form an e-mail will be triggered to the MyMelanoma team prompting

2.3.1.     checking of the nature of the consent

2.3.2.     dispatch of the first blood and stool test kits

2.3.3.     an e-mail to the participant seeking completion of the first on line questionnaire

3. The nature of consent: the participant will be asked to consider consenting to the following:-

3.1.  The retention of identifiers such as name, date of birth, address (postal and e-mail) and telephone number, for 20 years or until/unless the participant decides to with draw from the study.

3.1.1.     This consent is sought with the proviso that the data will be held securely and accessed only by staff authorised to do so restricted to:-

3.1.2.     MyMelanoma staff responsible for direct contact with participants

3.1.3.     MyMelanoma staff who must provide these personal details to those employed by the NHS or Public Heath England, who require those details to link the research data with the participants’ medical records (see point 6 below) or to trace stored tumor/ tissue samples.

3.1.4.     That the identifiers will never be available to the research staff whether within MyMelanoma or researchers who use the data generated.

3.2.  Completion of a REDCap questionnaire on line within 6 weeks which seeks information on personal and family health and lifestyle.REDCap  software will trigger a reminder email if the questionnaire is not completed in time.

3.3.  To having a blood test within 2 months of first diagnosis of melanoma (Route of Entry 1) or prior to the start of treatment (Route of Entry 2). The samples collected would be:-

3.3.1.     germline (blood) DNA which will be used to study inherited genes associated with an increased risk of cancer

3.3.2.     germline (blood) DNA which will be used to study inherited genes which are associated with differences in survival and side effects from treatment

3.3.3.     RNA from stored paraffin embdedded tumours which will be used to look at genes whose expression determines how aggressive tumors are, the effects of various environmental and lifestyle factors (eg smoking) on the tumors and whether the host can mount an immune response to the cancer. DNA from tumours will be extracted for sequencing.

3.3.4.     Other components of the blood (serum and plasma) which can be used to measure the levels of important proteins and or circulating tumour DNA, or indeed to assess tests as yet undeveloped.

3.4.  To collect samples of stool/faeces into plastic bottles at recruitment for Route of Entry 1 and prior to therapy and at 3 weeks after starting therapy Route of Entry 2, when funded.

3.5.  To the storage of the blood and stool samples (or their derivatives) labelled by unique barcodes only, at the UK Biocentre for the generation of “core” data: test results which will be made available (anonymously) to scientists all over the world who seek to carry out research on melanoma and for additional tests in future years to be performed to meet the aims of MyMelanoma.

3.6.  Collection of identifiable information on the participants’ medical history from sources such as:

3.6.1.     Primary care records 

3.6.2.     Secondary care records

3.6.3.     Public Health England (PHE)

3.6.3.1.         Including cancer registration

3.6.3.2.         Data collected by PHE on hospital admission                       

3.6.3.3.         Prescription records

3.6.3.4.         Death certification

3.7.  Being contacted annually for participants recruited via Route of Entry 1

3.7.1.     For completion of a brief on line questionnaire

3.7.2.     To consider taking part in additional projects as they may occur

3.7.3.     To allow requests for study newsletters

3.7.4.     To consider giving additional blood and/or stool samples

3.8.  To give consent to access to tissue samples stored within NHS laboratories after surgery including harmless moles removed in the past and tumor samples.These stored samples are kept, embedded in wax in the laboratories for further reference if needed. In consenting participants samples will be taken from those was blocks either in slices (sections) or as tiny cores of tissue, up to 1.5mm in diameter. Sometimes such wax blocks are needed by the patient, for example tests might be needed of the tissue in order to choose the best treatments for that person in the future. The samples for research will therefore be limited by the need to preserve sufficient tissue in case it is needed. The research samples will be used:-

3.8.1.     To extract DNA and RNA in order to study the genetic materials in the tissues

3.8.2.     To carry out studies of the role of specific proteins in melanoma or the patient’s response to the tumor

3.8.3.     The sections will be scanned into computer systems designed to develop computerised measurements which show how aggressive the tumors are and which treatments

3.9.  Collaboration with industry/business

3.9.1.     Many developments in medical care require or benefit from academic collaboration with industry and MyMelanoma will collaborate with these agencies to develop an open resource for the benefit of future patients. It will be made clear to potential participants that they are being asked to consent to this with the proviso that data security will be maximal. No identificable data would ever be released.