Effectiveness of monitoring levels of Circulating Tumour Cells (CTCs) in blood for early detection and treatment monitoring in cancer patients.

Determining levels of Circulating Tumour Cells (CTCs) in blood for early detection and real-time treatment monitoring in cancer patients.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617001496303

Enrollment

300

Registered

2017-10-24

Start date

2018-01-01

Completion date

Unknown

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this project is (1) to determine effectiveness of monitoring a cancer patient’s response to his/her treatment by detecting and counting the Circulating Tumour Cells (CTCs) in the bloodstream, and (2) to establish the relationship of the number of CTCs in patients before and after cancer diagnosis. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are about to start treatment for cancer (Part 1) or if you a healthy individual not previously diagnosed with cancer (Part 2). Study details For both groups, blood samples will be collected at various timepoints to assess CTCs number. In participants commencing cancer treatment this will be over a 12 month period while healthy individuals will be assessed once a year for 10 years. Upon the completion of this study, we will be able to evaluate the feasibility of using CTCs number as an indicator or marker for early cancer detection and for cancer treatment monitoring for cancer patients.

Interventions

Treatment Monitoring: CTCs will be enriched from whole blood sample (7.5ML in EDTA) using microfluidics. The recovered CTCs will be labelled and analysed within one week before treatment starts to create a baseline, and 3 months after treatment cycle started, and at least 3 weeks after treatment cycle ends as follow-up. There will be additional follow-ups at the 6th, 9th and 12th month after treatment. Early Detection: Healthy individuals and individuals with a family history of cancer or predisposition to cancer will fall under this group. 7.5ML of blood in EDTA will be taken from these participants and analysed for CTCs (to create the baseline). A follow-up blood test will be done yearly for another 9 years after the first test. Every year, the participant will also be asked if he/she has been diagnosed with cancer within the last 12 months. The full set of yearly CTCs results and trends will be studied and analysed.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Treatment Monitoring: Patients diagnosed with cancer who will be starting treatment. Treatment may include chemotherapy, radiotherapy, immunotherapy and other treatments as prescribed by the treating physician. Early Detection: Healthy individuals or individuals with history of family cancer and other predispositions to cancer.

Exclusion criteria

Cancer patients who already have completed their treatment more than 6 months ago.

Outcome results