Prospective Tissue Collection Research Protocol

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    400
  • sponsor
    Achilles Therapeutics UK Limited
Updated on 26 May 2022
cancer
breast cancer
lung cancer
metastasis
neutrophil count
blood transfusion
aptt

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.

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.

Details
Condition Solid Tumor
Treatment Tumour tissue collection
Clinical Study IdentifierNCT03517917
SponsorAchilles Therapeutics UK Limited
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
White cell count ≥ 3 x 10^9/L
Negative laboratory test for blood borne pathogens (see exclusion criterion)
For selected solid tumours and leukapheresis procedure additional inclusion criteria apply

Exclusion Criteria

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 have received any cytotoxic therapy (including investigational products) within three weeks prior to tissue procurement
For selected solid tumours and leukapheresis procedure additional exclusion criteria apply
Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue
For selected solid tumours additional exclusion criteria may apply
Patients who are currently participating in a clinical trial involving an unlicensed medical product
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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