NCT03517917

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2024

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

6.7 years

First QC Date

April 25, 2018

Last Update Submit

May 20, 2025

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Obtaining samples for research

    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

Study Arms (1)

Arm 1

Tumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed.

Other: Tumour tissue collection

Interventions

Tumour tissue collectionOTHER

Collection of tumour tissue and blood

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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).

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

New York, New York, 10065, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Georgetown, Washington, 20057, United States

Location

Research Site

Barcelona, 08036, Spain

Location

Research Site

Barcelona, 08908, Spain

Location

Research Site

Madrid, 28040, Spain

Location

Research Site

Madrid, 28050, Spain

Location

Research Site

Glasgow, G51 4TF, United Kingdom

Location

Research Site

Leeds, LS9 7TF, United Kingdom

Location

Research Site

London, NW1 2PG, United Kingdom

Location

Research Site

London, NW3 2QG,, United Kingdom

Location

Research Site

London, SE1 9RT, United Kingdom

Location

Research Site

London, SW3 6JJ, United Kingdom

Location

Research Site

London, SW3 6NP, United Kingdom

Location

Research Site

Manchester, M23 9LT, United Kingdom

Location

Research Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Research Site

Southampton, SO16 6YD, United Kingdom

Location

Research Site

Uxbridge, UB9 6JH, United Kingdom

Location

Related Links

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 8, 2018

Study Start

February 8, 2018

Primary Completion

October 8, 2024

Study Completion

October 8, 2024

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations

ES(4)GB(11)US(3)