Prospective Tissue Collection Research Protocol

Completed

Conditions studied: Solid Tumor

In brief

This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies.

Key facts

Study ID: NCT03517917
Run by: AstraZeneca
People needed: 221
Starts: 2018-02-08
Expected to finish: 2024-10-08
Last updated by the study team: 2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — New York, New York, United States
Research Site — Durham, North Carolina, United States
Research Site — Georgetown, Washington, United States
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Glasgow, United Kingdom
Research Site — Leeds, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Newcastle upon Tyne, United Kingdom
Research Site — Southampton, United Kingdom
Research Site — Uxbridge, United Kingdom

Full record on ClinicalTrials.gov

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