Solid Tumor Clinical Trial
Official title:
Prospective Collection Tissue Research Protocol
This study aims to collect matched donor tissue and blood to enable the development of a manufacturing process for potential immunotherapies.
This study intends to collect tumour tissue that would otherwise be discarded and 150 mLs of
blood from consenting patients for the development of manufacturing processes for potential
immunotherapies.
Suitable patients will provide consent at the first patient visit. Baseline assessments as
per standard of care and a record of patient demographics will be taken for visit 1. Details
will also be collected about current medical conditions and procedures and current
medications. Patients will be tested for infectious diseases e.g. HIV, Human T-cell
lymphotropic virus (HTLV), Hepatitis B, C and syphilis.
Visit 2: At this visit suitable patients who have met all the inclusion and exclusion
criteria and have a negative infectious disease screen test result at screening will attend
for either tissue sampling (take a small piece of tissue of the tumour) or tumour resection
(removal of cancerous growth) whichever is the most appropriate treatment for them as
dictated by the hospitals' own procedures and care pathways. The patient will also donate 150
mls of blood. This procedure is outside the standard of care.
All donated samples will be couriered to the specialist Sponsor laboratory with appropriate
oversight.
Visit 3 (Day 42 ±14 days) Following standard of care procedure, patients will receive their
standard follow up care. For this protocol a follow up telephone call will be made to ensure
patients have recovered fully.
This then concludes the patients' participation in the study.
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