Prospective Tissue Collection Research Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-08

Study Completion Date

2024-10-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Solid Tumor

Study Groups

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Arm 1

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

Tumour tissue collection

Intervention Type OTHER

Collection of tumour tissue and blood

Interventions

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Tumour tissue collection

Collection of tumour tissue and blood

Intervention Type OTHER

Eligibility Criteria

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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).

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No