Prospective Tissue Collection Research Protocol

May 20, 2025 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 08908
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28050
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Research Site
      • London, United Kingdom, NW1 2PG
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • London, United Kingdom, SW3 6NP
        • Research Site
      • London, United Kingdom, NW3 2QG,
        • Research Site
      • Manchester, United Kingdom, M23 9LT
        • Research Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Research Site
      • Southampton, United Kingdom, SO16 6YD
        • Research Site
      • Uxbridge, United Kingdom, UB9 6JH
        • Research Site
  • United States
    • New York
      • New York, New York, United States, 10065
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Washington
      • Georgetown, Washington, United States, 20057
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
Tumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed.
Other: Tumour tissue collection
Collection of tumour tissue and blood
Other Names:
  • Blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtaining samples for research
Time Frame: 5 years
This protocol does not have an analysis primary outcome measure. It will be conducted in accordance with the principles of Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Medical Monitor, MD, Achilles Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Actual)

October 8, 2024

Study Completion (Actual)

October 8, 2024

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ATX-MAP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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