Ongoing Studies Seeking participants

Circulating Tumour Cells (CTC) Study

NIIM conducts the Circulating Tumour Cells (CTC) Test as part of a clinical study.

This study is registered on the Australia New Zealand Clinical Trial Registry as observational (non-interventional) study, and has been approved by an NHMRC registered ethics committee.

This observational CTC study uses the ISET® system, developed by Rarecells Diagnostics SAS, France to detect Circulating Tumour Cells (CTC) and other rare cells in the blood. The ISET® system is CE IVD certified and is compliant with the European In Vitro Diagnostics Regulations.

The CTC blood Test is a one-point-in-time screening test.

Our study aims to

  • Assist in monitoring treatment effectiveness in cancer patients by CTC Testing before and after treatment
  • Screen for CTC to assist in early diagnosis of potential malignancy
  • Screen for other rare cells
  • Assess utility of the ISET-CTC test in clinical practice

What is Circulating Tumour Cell (CTC) analysis?

The ISET-CTC Test

  • The ISET-CTC Test is a screening test not a diagnostic test
  • CTC are Circulating Tumour Cells in the blood
  • CTC provide a biomarker for early cancer prognosis and treatment effectiveness
  • The ‘number of CTC’ or ‘CTC count’ indicates the risk of malignancy or the stage of cancer
  • The ‘Isolation by SizE of Tumour (ISET) CTC’ test uses filtration and standard cytological microscopy, validated in more than 80+ peer-reviewed articles over the last 20 years. Articles can be downloaded at: https://www.rarecells.com/iset-publications-in-oncology
  • As of Aug 2024, NIIM has conducted over 4,200 CTC tests.
  • Some facts about ISET-CTC Test

What does the CTC screening test involve?

  • TA doctor’s referral is required to book in for the ISET-CTC blood test.
    Contact: [email protected] for the CTC test request form
  • Bloods can be taken at NIIM or your local pathology lab. There is no need to fast for this blood test.
  • For interstate patients, please request a test kit, which includes blood tubes, packaging material, and a courier return envelope.
  • Your blood will be processed in the NIIM lab, Melbourne
  • The CTC report will be sent to your referring doctor to discuss with you. The turn-around time is usually 2 weeks.

The CTC test is not a standalone diagnostic test, and should be interpreted together with other clinical patient data.

NIIM Publications

Ried_Poster_CTC-screening_COSA2017

News

Information for Practitioners and Participants

Some FACTS about the ISET-CTC Test:

  • FACT 1: The ISET-CTC test can detect Circulating Tumour Cells (CTC) in all cancer types, including solid tumours and blood type cancers.
  • FACT 2: The ISET-CTC test can detect small cell cancer cells. ISET-CTC (Isolation by SizE of Tumour Cells) testing by microfiltration can detect cancer cells of all sizes. Cancer cells usually are larger than 8 microns (the ISET filter hole size), including solid tumour cells of 11.7-23.8 microns, small-cell type cancers (e.g. small cell lung carcinoma of 7.2-10 microns) and blood type cancers (e.g. leukemia cells of 8.9-15.3 microns).​​
  • FACT 3: The ISET-CTC can detect Circulating Tumour Cells (CTC) independent of the presence of Epithelial Cell Adhesion Molecule (EpCAM) markers.
    • Some tumour cells do not have EpCAM markers, e.g. blood type tumours. -> FALSE NEGATIVES
    • Tumour cells consistently undergo change and may lose EpCAM markers over time. -> FALSE NEGATIVES
    • Immune cells can display EpCAM markers, and in an inflammatory condition, this can produce FALSE POSITIVES
  • FACT 4: The ISET-CTC testing can distinguish between malignant Circulating Tumour Cells (CTC) and benign Circulating Epithelial Cells (CEC).

References

About ISET-CTC – https://www.rarecells.com/clinical-applications-2
80+ peer-reviewed articles on ISET-CTC testing are available at: https://www.rarecells.com/iset-publications-in-oncology

Key articles:

  • Ilie M et al. “Sentinel” Circulating Tumor Cells allow early diagnosis of lung cancer in patients with chronic obstructive pulmonary disease. Plos One 2014;9(10):e111597.
  • Cristofanilli M et al. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med 2004;351(8):781-91.​​
  • Yan WT et al. Circulating tumour cell status monitors the treatment responses in breast cancer patients: a meta-analysis. Scientific Reports 2017;7: 43464.
  • Wang C et al. Longitudinally collected CTCs and CTC-clusters and clinical outcomes of metastatic breast cancer. Breast Cancer Res Treat 2017;161(1):83-94.
  • Vona G et al. Isolation by size of epithelial tumor cells : a new method for the immunomorphological and molecular characterization of circulating tumor cells. Am J Pathol 2000;156(1):57-63.
  • Laget S et al. Technical insights into highly sensitive isolation and molecular characterization of fixed and live circulating tumor cells for early detection of tumor invasion. PloS One 2017, 12(1), p.e0169427.
  • Ried K, Eng P, Sali A. Screening for Circulating Tumour Cells allows early detection of cancer and monitoring of treatment effectiveness: an observational study. Asian Pac J Cancer Prev 2017; 18: 2275-2285.
  • Ried K, Tamanna T, Matthews S, Eng P, Sali A. New Screening Test improves Detection of Prostate Cancer using Circulating Tumour Cells and Prostate-specific Markers. Frontiers Oncol Apr 2020, 10, 582. https://www.frontiersin.org/articles/10.3389/fonc.2020.00582/full
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