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Trial registered on ANZCTR


Registration number
ACTRN12620001353987
Ethics application status
Approved
Date submitted
28/07/2020
Date registered
15/12/2020
Date last updated
15/12/2020
Date data sharing statement initially provided
15/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
FORECAST 1. Feasibility of using Organoid Response to find Effective Treatments for patients with Colorectal cancer After failure of Standard Therapy
Scientific title
Feasibility of using Organoid Response (Patient derived tumour organoids obtained by biopsy) to find Effective Treatments for patients with Colorectal cancer After failure of Standard Therapy
Secondary ID [1] 301900 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
FORECAST 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
318407 0
Condition category
Condition code
Cancer 316422 316422 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This feasibility study involves the collection of fresh tumour tissue from patients with Metastatic Colorectal Cancer ( mCRC) for the purposes of establishing organoid model cultures.Participants will be asked to provide up to 3 tumour tissue samples(depending on size of the tumour) from a once only biopsy. This as an above standard of care, separate procedure. The mode of biopsy will be dependent on the site metastatic disease. Radiological imaging will be used to locate the secondary cancer sites, for example an ultrasound or CT scan.The biopsy will be performed by an interventional radiologist . The biopsy process is anticipated to take a 1 hour, though may vary depending on the site of disease. 20 mls of blood will be required from participants; the equivalent of 2 tablespoons. It is planned that this blood will be drawn at the biopsy visit.
Two visits to hospital are required, for informed consent discussion and for the biopsy itself.
These tumour samples will be used to develop patient derived tumour organoids (PDTO) or mini tumours. The PDTO will be used is to develop a drug sensitivity testing to predict therapeutic response.
This drug sensitivity reports are a research outcome, they are not validated or accredited and cannot be used as a recommendation for further treatment of the subject.
The therapeutic drug responses in these models with will be collated with detailed clinic-pathological, treatment and the clinical outcomes data for participants. This data will be collected from medical records or requested from referring physicians.
Intervention code [1] 318188 0
Other interventions
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324576 0
Feasibility will be assessed based on the number of PDTO successfully established for high throughput drug screening to guide clinical decision making.
Timepoint [1] 324576 0
4- 6 weeks post collection of biopsy
Secondary outcome [1] 385019 0
PDTO sensitivity will be tested using a high throughput drug panel. This panel will contain standard of care mCRC therapeutics and commonly used chemotherapy combinations as well as available , but not commonly used cancer therapeutics which may be repurposed for the Metastatic Colorectal cancer.
The optimal sequence will be assessed by which therapeutics the PDTO shows best response to.


Timepoint [1] 385019 0
Participants clinical outcomes date of disease progression, or ongoing treatment at 3 month intervals

Eligibility
Key inclusion criteria
1. Able to provide informed, voluntary, written consent
2. Have a diagnosis of metastatic colorectal cancer
3. Are able to safely undergo biopsy to provide samples of fresh tumour
4. ECOG performance status of 0-2
5. Have adequate major organ function
6. Fit for further systemic treatment
7. Have failed or are intolerant of standard therapies (excluding trifluridine/tipiracil)
8. Prior systemic treatment must have discontinued at least 2 weeks prior to enrolment onto the study
9. Have a life expectancy of > 3 months
10. Are accessible for follow up and de-identified coded data collection
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a condition that interferes with their ability to provide informed consent or comply with the protocol
2. Unable to provide tissue samples for any reason


Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Adherence rate of 70% with confidence interval in PDTO informed treatment population to define the feasibility of the next study. Using the method of Mehta-Cain a total sample size of 30 patients will be recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17158 0
Western Hospital - Footscray - Footscray
Recruitment hospital [2] 17159 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 17160 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 17161 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [5] 17162 0
Melbourne Private Hospital - Parkville
Recruitment hospital [6] 17163 0
The Northern Hospital - Epping
Recruitment hospital [7] 17164 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 30839 0
3011 - Footscray
Recruitment postcode(s) [2] 30840 0
3128 - Box Hill
Recruitment postcode(s) [3] 30841 0
3084 - Heidelberg
Recruitment postcode(s) [4] 30842 0
3844 - Traralgon
Recruitment postcode(s) [5] 30843 0
3052 - Parkville
Recruitment postcode(s) [6] 30844 0
3076 - Epping
Recruitment postcode(s) [7] 30845 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 306316 0
Other Collaborative groups
Name [1] 306316 0
Australasian Gastro-Intestinal Trials Group (AGITG)
Address [1] 306316 0
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country [1] 306316 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Address
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 306811 0
None
Name [1] 306811 0
Address [1] 306811 0
Country [1] 306811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306529 0
Melbourne Health Human Research and Ethics Committee
Ethics committee address [1] 306529 0
Royal Melbourne Hospital
Grattan St
Parkville 3052
Victoria
Ethics committee country [1] 306529 0
Australia
Date submitted for ethics approval [1] 306529 0
29/01/2020
Approval date [1] 306529 0
30/03/2020
Ethics approval number [1] 306529 0
HREC/61231/MH-2020

Summary
Brief summary

This feasibility study aims to determine whether a drug screening model can be created using tumour cells from patients with metastatic colorectal cancer that have not been responsive to previous treatments.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with metastatic colorectal cancer (cancer that has spread to another part of the body) that has so far been unresponsive to or has progressed through other cancer treatments.
Study details
Participants in this study will undergo a tumour biopsy procedure. For this procedure, a tissue sample will be taken under radiological imaging, by an experienced doctor. The tissue sample will then be used in laboratory tests by the research team to determine how the cells react to different types of drugs. Participants will also have information about their specific disease characteristics, treatments administered and the outcome of each treatment collected by their doctor as is usual practice. This information will also be shared with the research team to further their understanding of disease-drug interactions.

It is hoped this research may be used to improve health outcomes for future patients with metastatic colorectal cancer by determining whether it is possible to create a specific tumour cell drug screening model to test the effectiveness of cancer drugs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104174 0
Prof Peter Gibbs
Address 104174 0

Personalised Oncology
Walter and Eliza Hall Institute of Medical Research
1g Royal Parade Parkville 3052
Victoria
Country 104174 0
Australia
Phone 104174 0
+61 3 9345 2897
Fax 104174 0
+61 3 9498 2010
Email 104174 0
Peter.gibbs@mh.org.au
Contact person for public queries
Name 104175 0
Ms Helen Brasier
Address 104175 0

Personalised Oncology
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade Parkville 3052
Victoria
Country 104175 0
Australia
Phone 104175 0
+61 3 9345 2839
Fax 104175 0
+61 3 9498 2010
Email 104175 0
helen.brasier@mh.org.au
Contact person for scientific queries
Name 104176 0
Prof Peter Gibbs
Address 104176 0
Personalised Oncology
Walter and Eliza Hall Institute of Medical Research
1g Royal Parade Parkville 3052
Victoria

Country 104176 0
Australia
Phone 104176 0
+61 03 9345 2897
Fax 104176 0
+61 3 9498 2010
Email 104176 0
Peter.gibbs@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data generated from this study will remain confidential and no published report will contain any reference to patient names. The patient identification required is used to ensure accurate storage and follow-up of individual patients. Due to the small number of participants and the small number of participating sites , release of IPD may not guarantee that subjects identity will remain confidential. The data generated will be in the form of an aggregated report only with no personal identifiers used. This information will be stored securely at WEHI and will only be available to data management, audit or monitoring personnel directly involved with the study. All study related personnel are bound by professional standards of patient information confidentiality and will work to protect patient confidentiality at all times
What supporting documents are/will be available?
No other documents available
Summary results
No Results