Prospective Tissue Collection Research Protocol

During standard of care surgery tumour samples which are surplus to the requirements of the patients diagnostic/treatment pathway will be procured along with a matched whole blood and/or leukapheresis sample. In some instances patients may consent to provide a non-standard of care, non-invasive research biopsy.

Within 28-42 days following procurement of samples patients will be required to participate in a safety follow up call for assessment of any procedure related adverse events.

Inclusion criteria

• Aged ≥ 18 years
• Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation.
• Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease.
• Patient is scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy, has a superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.
• Haemoglobin(Hb) ≥ 10g/dL without transfusion support for at least 3 weeks (for patients donating whole blood).

White cell count ≥ 3 x 10^9/L (for patients donating whole blood).

• For selected solid tumours and leukapheresis procedure additional inclusion criteria apply.

Exclusion criteria

• Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue.
• Inadequate peripheral venous access precluding collection of blood.
• Pregnant or breastfeeding women.
• Known/laboratory confirmed diagnosis of an active infectious disease to include Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis.
• Patients who are currently participating in a clinical trial involving an unlicensed medical product.
• Patients who have received any cytotoxic therapy (including investigational products) within three weeks prior to tissue procurement.
• Patients receiving immunosuppressive treatments or who require regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).
• Any medical reason why, in the opinion of the investigator, the patient should not participate in this study.
• For selected solid tumours and leukapheresis procedure additional exclusion criteria apply.