Clinical trial NCT03517917: Prospective Tissue Collection Research Protocol
Official title: Prospective Collection of Donor Tissue and Whole Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid tumour scheduled for either biopsy or resection of their tumour(s) as part of their standard of care, and patients with superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Obtaining samples for research
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Georgetown
country: United States
facility: Research Site
state: Washington
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Uxbridge
country: United Kingdom
facility: Research Site
Study officials:
References: