Prospective Tissue Collection Research Protocol

STATUS

Recruiting
End date

Aug 31, 2025
participants needed

400
sponsor

Achilles Therapeutics UK Limited

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Updated on 26 May 2022

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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 Identifier	NCT03517917
Sponsor	Achilles Therapeutics UK Limited
Last Modified on	26 May 2022

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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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Step 4 Get your study results

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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Prospective Tissue Collection Research Protocol