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Prospective Tissue Collection Research Protocol
Prospective Tissue Collection Research Protocol

NCT03517917

CompletedN/A

Sponsor: AstraZeneca

Conditions: Solid Tumor

Interventions: Tumour tissue collection

Countries: United States, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (18)
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Georgetown, Washington, United States
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Glasgow, United Kingdom
  • Leeds, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Newcastle upon Tyne, United Kingdom
  • Southampton, United Kingdom
  • Uxbridge, United Kingdom