Recruitment process
We are initially seeking referrals from clinicians for patients they believe meet the criteria, after discussing the program with their patient.
The clinician can then refer the patient to us via a standard medical referral. Referrals can be made via the following:
Email: patient@exceptionalresponder.com.au
- Referral form – main project (Word doc)
- Referral form – bleomycin substudy (Word doc)
Fax: 1800-PATIENT
When we receive a referral, we will contact the referring clinician to discuss the case. Following this, we will arrange a Telehealth consultation with the patient, to discuss the study and gain his or her consent.
We will then collect relevant clinical details regarding the case, and review the case for inclusion in the study (clinical sub-committees).
If the case is clinically suitable for inclusion, we will contact the treating institution to arrange retrieval of archival tissue, and contact the patient to obtain a single (one-off) blood sample (2x10mL tubes).
Once we have the biological materials, we will review the case with our scientific and steering committees.
We will communicate with the referring clinician following clinical review (1), steering committee review (2), prior to analysis (3) and as the case progresses.
What is an Exceptional Response?
There are many variables of treatment response (related to drug, host and cancer) and mechanisms of response are often multifactorial.
Generally, cases should meet these quantitative criteria:
- A CR or PR to a drug or other treatment, where <10% of patients would be expected to respond
- A CR or PR that lasts > 3 times the median / expected PFS
- Best response PD where >90% of patients would be expected to respond.
Qualitative assessment is tumour specific. Cases will be discussed by a tumour-specific sub-committee, taking into consideration aspects such as the natural history of the disease and previous treatment response.
Selection criteria
Whilst there are no firm inclusion or exclusion criteria the following principles will generally apply to patients entered into this protocol:
- The patient must have a clinically appropriate exceptional response as noted by their treating clinician and agreed by the steering committee. The exact definition of this is adaptable to the disease.
- The patient must have tumour and normal tissue (e.g., blood, buccal swab) available for analyses.
- Patients with non-favourable exceptional response will also be considered for inclusion (eg chemotherapy resistance in conventionally chemo-sensitive tumours, hyperprogression as response to immune therapy).
Please contact us for further clarification of the above.