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 

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

What is Circulating Tumour Cell (CTC) analysis?


  • 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 2021, NIIM has conducted over 2,800 CTC tests.
  • Some facts about ISET-CTC Test

What does the CTC screening test involve?

  1. A doctor’s referral is required to book in for the ISET-CTC blood test.
    Contact: research@niim.com.au for the CTC test request form
  2. Bloods can be taken at NIIM or your local pathology lab. There is no need to fast for this blood test.
  3. For interstate patients, please request a test kit, which includes blood tubes, packaging material, and a courier return envelope.
  4. Your blood will be processed in the NIIM lab, Melbourne.
  5. 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.

2. 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


Listen to A/Prof Karin Ried on a ‘Metagenics Clinical Podcast’ – Screening for Circulating Tumour Cells (CTC) – June 17, 2020

Prostate Cancer Screening Study – Call for participants – 2 July 2020


Information for Practitioners and Participants

Participation in the CTC trial is by practitioner’s referral only.

For more information & Expressions of Interest

View ANZ Clinical trial registry

Contact the NIIM Research Team
P: 03 9912 9580
E:  research@niim.com.au


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).


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:

  1. 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.
  2. Cristofanilli M et al. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med 2004;351(8):781-91.
  3. Yan WT et al. Circulating tumour cell status monitors the treatment responses in breast cancer patients: a meta-analysis. Scientific Reports 2017;7: 43464.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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