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Trial registered on ANZCTR


Registration number
ACTRN12614001143617
Ethics application status
Approved
Date submitted
6/10/2014
Date registered
29/10/2014
Date last updated
24/04/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining Circulating Tumour Cells (CTC) and other rare cells in cancer patients and for early detection screening
Scientific title
Determining Circulating Tumour Cells (CTC) and other rare cells in cancer patients before and after treatment and for early detection screening using ISET (Isolation by Size of Epithelial/ Trophoblastic Tumour Cells) technology
Secondary ID [1] 285447 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 293214 0
Chronic illness due to infection 294539 0
Condition category
Condition code
Cancer 293483 293483 0 0
Any cancer
Infection 294848 294848 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3-12
Target follow-up type
Months
Description of intervention(s) / exposure
Monitoring test: Circulating tumour cells are isolated from blood (10 ml in ACD) by ISET (Isolation by Size of Epithelial Tumour Cells) using filtration technology and analysed within one week before treatment (baseline) and at 3 months after treatment cycle commenced and at least 3 weeks after treatment cycle ceased (follow-up) - primary outcome measure
Follow-up at 6 months, 9 months and 12 months, if applicable (secondary outcome measures)

Screening test: Early detection in patients with a family history of cancer or patients with chronic disease, or as part of a health check. The ISET-ED (early detection screening) test has the potential to detect potentially malignant cells, and other illness causing rare cells.
Circulating rare cells are isolated from blood (10 ml in ACD) by ISET technology and analysed at baseline and at 3-12 months (follow-up)
Intervention code [1] 290379 0
Not applicable
Comparator / control treatment
Intra-individual: Number of CTC at follow-up (e.g. after treatment) compared to number of CTC at baseline (e.g. before treatment). Detection of rare cells at follow-up compared with baseline.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293304 0
Change in number of CTC and other rare cells using blood filtered by ISET technology
Timepoint [1] 293304 0
3 months after baseline (e.g. treatment cycle commenced), and at least 3 weeks after treatment cycle ceased (follow-up)
Secondary outcome [1] 310773 0
type of CTC / rare cells using ISET technology
Timepoint [1] 310773 0
3 months after baseline (e.g. treatment cycle commenced), and at least 3 weeks after treatment cycle ceased (follow-up)
Secondary outcome [2] 311062 0
Optional CTC count including assessment of CTC type at 6, 9, 12 months after commencement of treatment using ISET technology.
Timepoint [2] 311062 0
6, 9, 12 months after commencement of treatment

Eligibility
Key inclusion criteria
treatment effectiveness: Patient diagnosed with cancer;
Have previously received (at least 3 weeks ago) or will receive treatment within one week;
treatment may include chemotherapy, radiotherapy, hyperthermia, intravenous Vitamin C, or other complementary treatment as prescribed by the treating physician;

Early detection screening: Patients with a family history of cancer or patients with chronic disease, or as part of a health check
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no exclusion

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
1-way repeated measures ANOVA;
The sample size is primarily based on clinical availability of patients. A sample size of 50-100 patients would be sufficient to detect a change of >50% in CTC numbers at follow-up compared to baseline with the power of 90% and a confidence of 95%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/10/2014
Actual
6/10/2014
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
1500
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA

Funding & Sponsors
Funding source category [1] 290055 0
Charities/Societies/Foundations
Name [1] 290055 0
National Institute of Integrative Medicine
Country [1] 290055 0
Australia
Primary sponsor type
Individual
Name
Dr Karin Ried
Address
National Institute of Integrative Medicine
11-23 Burwood Rd
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 288743 0
None
Name [1] 288743 0
Address [1] 288743 0
Country [1] 288743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291761 0
NIIM HREC
Ethics committee address [1] 291761 0
National Institute of Integrative Medicine
11-23 Burwood Rd
Hawthorn, VIC 3122
Ethics committee country [1] 291761 0
Australia
Date submitted for ethics approval [1] 291761 0
14/08/2014
Approval date [1] 291761 0
18/08/2014
Ethics approval number [1] 291761 0
EC00436

Summary
Brief summary
Treatment effectiveness:
This study will determine whether there is a difference between the number and type of circulating tumour cells in cancer patients before and after treatment.

Who is it for?
You may be eligible to join this study if you are aged 18-80 years, diagnosed with any cancer and have received treatment at least 3 weeks ago or will receive treatment within one week.

Study details
The study aims to establish the Circulating Tumour Cell (CTC) detection method using the ISET (Isolation by Size of Epithelial/Trophoblastic Tumour Cells) device (Rarecells, France) in conjunction with cancer therapies offered at National Institute of Integrative Medicine. There will be no changes to the participants’ cancer treatment plans. Participants will be required to provide a blood sample at the beginning of their treatment and 3 months after commencement of treatment. The blood will be processed using the ISET technology to determine the number and types of circulating tumour cells.

Early detection screening:
This component of the study aims to determine whether the ISET-ED screening blood test can be used for early detection of cancer.
Who is it for?
You may be eligible to join this part of the study if you are aged between 18-80 years and have a family history of cancer, or have been diagnosed with chronic disease, or are attending a health check.
Study details:
Participants in this part of the study will undergo a blood test at baseline and at 3 months.
The ISET-ED (early detection screening) test has the potential to detect potentially malignant cells, and other illness causing rare cells.
Trial website
www.niim.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51842 0
A/Prof Karin Ried
Address 51842 0
National Institute of Integrative Medicine
11-23 Burwood Rd
Hawthorn, VIC 3122
Country 51842 0
Australia
Phone 51842 0
+61 3 9912 9545
Fax 51842 0
+61 3 9804 0513
Email 51842 0
karinried@niim.com.au
Contact person for public queries
Name 51843 0
A/Prof Karin Ried
Address 51843 0
National Institute of Integrative Medicine
11-23 Burwood Rd
Hawthorn, VIC 3122
Country 51843 0
Australia
Phone 51843 0
+61 3 9912 9545
Fax 51843 0
+61 3 9804 0513
Email 51843 0
karinried@niim.com.au
Contact person for scientific queries
Name 51844 0
A/Prof Karin Ried
Address 51844 0
National Institute of Integrative Medicine
11-23 Burwood Rd
Hawthorn, VIC 3122
Country 51844 0
Australia
Phone 51844 0
+61 3 9912 9545
Fax 51844 0
+61 3 9804 0513
Email 51844 0
karinried@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:

Updated to:
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.