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ANG-010 (INFORM Study)

  • Research type

    Research Study

  • Full title

    ANG-010 INFORM Study: Optimization of Devices and Assays for the Harvest, Evaluation and Characterization of Rare Cells from Patients with Advanced Stage Tumors

  • IRAS ID

    309508

  • Contact name

    Anne-Sophie Pailhes-Jimenez

  • Contact email

    a.pailhes-jimenez@angleplc.com

  • Sponsor organisation

    ANGLE plc

  • Duration of Study in the UK

    5 years, 0 months, 1 days

  • Research summary

    ANGLE’s Parsortix® system is a semi-automated platform capable of capturing rare cells from blood, including Circulating Tumour Cells (CTCs), based on cell size and deformability, and allows subsequent harvesting of the captured cells for subsequent evaluation. Due to difficulties in obtaining solid tumour samples from sites of metastases to enable ongoing clinical assessment, harvesting CTCs from ‘liquid biopsies’ of the patient’s peripheral blood is an area of substantial research interest, with the goal of developing non-invasive blood-based tests to help guide patient treatment and monitor response to therapy.

    DNA, RNA, and proteins can be obtained from CTCs isolated from peripheral blood, with CTC culture also possible. The Parsortix® system addresses several issues encountered with other CTC capture technologies in that it does not use antibodies or other cell surface affinity agents to capture the target cells.

    In this study, up to 1,000 patients with advanced cancers (breast, prostate, lung, ovarian), being treated for their disease with oral and/or systemic therapies will be consented and enrolled. Following enrolment, research blood samples will be collected prior to- the next administration of treatment up to a maximum of six occasions over the course of their disease management, each blood collection being a minimum of 30 days apart.

    Collected blood will be sent to ANGLE to be processed on the Parsortix® system and the harvested cells will be evaluated using various techniques to assess the ability of ANGLE’s devices and assays to detect CTCs in the cancer types being studied, using different collection tube types and blood volumes. Where serial blood draws are available, changes in the number and phenotype/genotype of CTCs will be evaluated.

    The results from this study are intended to support the evaluation and further development/refinement of ANGLE’s cell separation, capture, harvesting and characterization devices and assays.

    Patients will be recruited from oncology hospitals in the UK, US and/or EU over a 3-5 year period.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    22/PR/0347

  • Date of REC Opinion

    9 Jun 2022

  • REC opinion

    Further Information Favourable Opinion