Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12620001353987
Ethics application status
Approved
Date submitted
28/07/2020
Date registered
15/12/2020
Date last updated
17/03/2023
Date data sharing statement initially provided
15/12/2020
Date results information initially provided
17/03/2023
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
Query!
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
Query!
Secondary ID [1]
301900
0
Nil Known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
FORECAST 1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
318407
0
Query!
Condition category
Condition code
Cancer
316422
316422
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
318188
0
Other interventions
Query!
Comparator / control treatment
no control group
Query!
Control group
Uncontrolled
Query!
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.
Query!
Assessment method [1]
324576
0
Query!
Timepoint [1]
324576
0
4- 6 weeks post collection of biopsy
Query!
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.
Query!
Assessment method [1]
385019
0
Query!
Timepoint [1]
385019
0
Participants clinical outcomes date of disease progression, or ongoing treatment at 3 month intervals
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/09/2020
Query!
Date of last participant enrolment
Anticipated
30/06/2021
Query!
Actual
21/10/2021
Query!
Date of last data collection
Anticipated
30/06/2023
Query!
Actual
15/03/2023
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
30
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
17158
0
Western Hospital - Footscray - Footscray
Query!
Recruitment hospital [2]
17159
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [3]
17160
0
Austin Health - Austin Hospital - Heidelberg
Query!
Recruitment hospital [4]
17161
0
Latrobe Regional Hospital - Traralgon
Query!
Recruitment hospital [5]
17162
0
Melbourne Private Hospital - Parkville
Query!
Recruitment hospital [6]
17163
0
The Northern Hospital - Epping
Query!
Recruitment hospital [7]
17164
0
Sunshine Hospital - St Albans
Query!
Recruitment postcode(s) [1]
30839
0
3011 - Footscray
Query!
Recruitment postcode(s) [2]
30840
0
3128 - Box Hill
Query!
Recruitment postcode(s) [3]
30841
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [4]
30842
0
3844 - Traralgon
Query!
Recruitment postcode(s) [5]
30843
0
3052 - Parkville
Query!
Recruitment postcode(s) [6]
30844
0
3076 - Epping
Query!
Recruitment postcode(s) [7]
30845
0
3021 - St Albans
Query!
Funding & Sponsors
Funding source category [1]
306316
0
Other Collaborative groups
Query!
Name [1]
306316
0
Australasian Gastro-Intestinal Trials Group (AGITG)
Query!
Address [1]
306316
0
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Query!
Country [1]
306316
0
Australia
Query!
Primary sponsor type
Other Collaborative groups
Query!
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Query!
Address
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Query!
Country
Australia
Query!
Secondary sponsor category [1]
306811
0
None
Query!
Name [1]
306811
0
Query!
Address [1]
306811
0
Query!
Country [1]
306811
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
306529
0
Melbourne Health Human Research and Ethics Committee
Query!
Ethics committee address [1]
306529
0
Royal Melbourne Hospital
Grattan St
Parkville 3052
Victoria
Query!
Ethics committee country [1]
306529
0
Australia
Query!
Date submitted for ethics approval [1]
306529
0
29/01/2020
Query!
Approval date [1]
306529
0
30/03/2020
Query!
Ethics approval number [1]
306529
0
HREC/61231/MH-2020
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
104174
0
Prof Peter Gibbs
Query!
Address
104174
0
Personalised Oncology
Walter and Eliza Hall Institute of Medical Research
1g Royal Parade Parkville 3052
Victoria
Query!
Country
104174
0
Australia
Query!
Phone
104174
0
+61 3 9345 2897
Query!
Fax
104174
0
+61 3 9498 2010
Query!
Email
104174
0
[email protected]
Query!
Contact person for public queries
Name
104175
0
Ms Helen Brasier
Query!
Address
104175
0
Personalised Oncology
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade Parkville 3052
Victoria
Query!
Country
104175
0
Australia
Query!
Phone
104175
0
+61 3 9345 2839
Query!
Fax
104175
0
+61 3 9498 2010
Query!
Email
104175
0
[email protected]
Query!
Contact person for scientific queries
Name
104176
0
Prof Peter Gibbs
Query!
Address
104176
0
Personalised Oncology
Walter and Eliza Hall Institute of Medical Research
1g Royal Parade Parkville 3052
Victoria
Query!
Country
104176
0
Australia
Query!
Phone
104176
0
+61 03 9345 2897
Query!
Fax
104176
0
+61 3 9498 2010
Query!
Email
104176
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
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
Query!
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
Source
Title
Year of Publication
DOI
Embase
Unified framework for patient-derived, tumor-organoid-based predictive testing of standard-of-care therapies in metastatic colorectal cancer.
2023
https://dx.doi.org/10.1016/j.xcrm.2023.101335
Dimensions AI
Beyond standard data collection – the promise and potential of BRAIN (Brain tumour Registry Australia INnovation and translation registry)
2022
https://doi.org/10.1186/s12885-022-09700-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF