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Trial registered on ANZCTR


Registration number
ACTRN12617001496303p
Ethics application status
Not yet submitted
Date submitted
18/10/2017
Date registered
24/10/2017
Date last updated
26/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of monitoring levels of Circulating Tumour Cells (CTCs) in blood for early detection and treatment monitoring in cancer patients.
Scientific title
Determining levels of Circulating Tumour Cells (CTCs) in blood for early detection and real-time treatment monitoring in cancer patients.
Secondary ID [1] 293162 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 305141 0
Condition category
Condition code
Cancer 304460 304460 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 299410 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303701 0
Percentage change in number of CTCs in the blood sample.
Timepoint [1] 303701 0
3 months after baseline (which is before treatment), and at least 3 weeks after treatment cycle ends.
Primary outcome [2] 303702 0
Number of CTCs in blood samples.
Timepoint [2] 303702 0
Once a year for 10 years.
Secondary outcome [1] 339903 0
Percentage change in number of CTCs.

The CTCs number is determined firstly by using microfluidics to enrich the CTCs, followed by antibody-based labelling and counting of CTCs under a fluorescent microscope. A percentage increase/decrease is derived after determining the difference between the previous and current reading.
Timepoint [1] 339903 0
At the 6th, 9th and 12th month after treatment for treatment response monitoring group.

Yearly till the 10th year after the first test for early detection group.
Secondary outcome [2] 339966 0
Relationship of CTC levels in the blood and cancer incidence.

The cancer incidence is assessed by a telephone or email follow-up directly with participants. Participants can also self-report by emailing us.
Timepoint [2] 339966 0
Once a year for 10 years.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cancer patients who already have completed their treatment more than 6 months ago.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/01/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment outside Australia
Country [1] 9296 0
Singapore
State/province [1] 9296 0
Country [2] 9297 0
China
State/province [2] 9297 0
Country [3] 9298 0
Korea, Republic Of
State/province [3] 9298 0
Country [4] 9299 0
United States of America
State/province [4] 9299 0

Funding & Sponsors
Funding source category [1] 297789 0
Commercial sector/Industry
Name [1] 297789 0
Survon Pte Ltd
Country [1] 297789 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
Survon Pte Ltd
Address
81 Ubi Avenue 4 #06-10
Singapore 408830
Country
Singapore
Secondary sponsor category [1] 296827 0
None
Name [1] 296827 0
Address [1] 296827 0
Country [1] 296827 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298848 0
Ethics committee address [1] 298848 0
Ethics committee country [1] 298848 0
Date submitted for ethics approval [1] 298848 0
30/11/2017
Approval date [1] 298848 0
Ethics approval number [1] 298848 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78434 0
Mr Mingwei Fan
Address 78434 0
Survon Pte Ltd
81 Ubi Avenue 4 #06-10
Singapore 408830
Country 78434 0
Singapore
Phone 78434 0
+65 65382838
Fax 78434 0
Email 78434 0
[email protected]
Contact person for public queries
Name 78435 0
Denise Loo
Address 78435 0
Survon Pte Ltd
81 Ubi Avenue 4 #06-10
Singapore 408830
Country 78435 0
Singapore
Phone 78435 0
+65 65382838
Fax 78435 0
Email 78435 0
[email protected]
Contact person for scientific queries
Name 78436 0
Mingwei Fan
Address 78436 0
Survon Pte Ltd
81 Ubi Avenue 4 #06-10
Singapore 408830
Country 78436 0
Singapore
Phone 78436 0
+65 65382838
Fax 78436 0
Email 78436 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.