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Trial registered on ANZCTR
Registration number
ACTRN12612000327886
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
21/03/2012
Date last updated
21/03/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Circulating Tumour DNA as a Marker of Complete Pathological Response and Long Term Outcome for Locally Advanced Rectal Cancer Treated with Pre-operative Chemoradiotherapy
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Scientific title
Circulating Tumour DNA as a marker of complete pathological response and long term outcome for locally advanced rectal cancer treated with pre-operative chemoradiotherapy.
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Secondary ID [1]
280186
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Nil
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Secondary ID [2]
280189
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Nil
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Universal Trial Number (UTN)
U1111-1129-1350
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Trial acronym
ctDNA Rectal cancer
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patients with locally advanced rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy.
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Nil
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Condition category
Condition code
Cancer
286264
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is an exploratory prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from patients with locally advanced
rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy. Patients will be treated and followed according to standard
practice.The collection of serial blood samples at specifed timepoints. The timepoints are as follows Timepoint 1 baseline (prior to chemo radiation), timepoint 2 4 – 6 weeks post chemo-radiation and the final timepoint (timepoint 3)being 4 – 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected. Each patient’s treating surgeon will assess and document the clinical response to CRT prior to surgery. Resected tumour samples will be made available after surgery for mutation analysis. If there is no or minimal residual disease in the resected specimen, then the preoperative diagnostic biopsy will be used. Histology slides will be made available for central assessment of pathological response to chemoradiation. Follow-up will be as per standard practice, including 3-monthly CEA and annual CT chest/abdomen/pelvis for at least 2 years.
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Intervention code [1]
284510
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Not applicable
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To demonstrate that the eradication of circulating tumour DNA (ctDNA) in peripheral blood following completion of pre-operative chemoradiotherapy (CRT) is a sensitive and specific predictor of complete pathological response (pCR) in locally advanced rectal cancer.
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Assessment method [1]
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Timepoint [1]
286727
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Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
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Secondary outcome [1]
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To demonstrate that a reduction in ctDNA following CRT is a sensitive and specific marker of pathological response in locally advanced rectal cancer.
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Assessment method [1]
296544
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Timepoint [1]
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Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
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Secondary outcome [2]
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To demonstrate that the persistence of ctDNA in peripheral blood, either following CRT or surgery, is a sensitive and specific predictor of subsequent local or distant disease recurrence.
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Assessment method [2]
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Timepoint [2]
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Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
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Secondary outcome [3]
296643
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To demonstrate that mutations detected in ctDNA reliably predict the mutation profile of the primary tumours of these patients.
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Assessment method [3]
296643
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Timepoint [3]
296643
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Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.
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Eligibility
Key inclusion criteria
1. Patients with histologically confirmed adenocarcinoma of the rectum
2. Patients with radiologically defined locally advanced disease on pelvic MRI (mT3, mT4 or mN+) or endorectal ultrasound (uT3, uT4 or uN1) where MRI is contraindicated)
3. No evidence of metastatic disease on CT chest/abdomen/pelvis
4. Patients planned to receive long-course chemoradiation followed by curative surgery and adjuvant 5-fluorouracil or capecitabine chemotherapy
5. Patients willing to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of another primary cancer within the last 5 years, with the exception of nonmelanomatous skin cancer and carcinoma in situ of the cervix.
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
3. Patients with major organ impairment
4. Patients that are not accessible for follow-up
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
320
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and medical Coucil
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Ludwig Institute for Cancer Research
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Address
PO Box 2008
RMH Post Office
Parkville VIC 3050 Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
283776
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Country [1]
283776
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Health HREC
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Ethics committee address [1]
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Post Office
Royal Melbourne Hospital
Parkville Victoria 3050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
286892
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Approval date [1]
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08/03/2012
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Ethics approval number [1]
286892
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HREC/11/MH/397
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Summary
Brief summary
Circulating Tumour DNA as a marker of complete athological response and long term outcome for locally advanced
rectal cancer treated with pre-operative chemoradiotherapy. The aim of the study is to demonstrate that the eradication of ctDNA in peripheral blood following completion of pre-operative chemoradiotherapy (CRT) is a sensitive and specific predictor of complete pathological response (pCR) in locally advanced rectal cancer
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Philippa Robertson
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Address
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PO Box 2008, RMH Post Office Parkville VIC 3050 Australia
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Country
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Australia
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Phone
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+61(3)9342 4584
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jeanne Tie
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Address
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PO Box 2008, RMH Post Office Parkville VIC 3050 Australia
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Country
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Australia
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Phone
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+61(3) 9342 3037
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Fax
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Email
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jeanne.tie@ludwig,edu.au
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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
Source
Title
Year of Publication
DOI
Embase
Serial circulating tumour DNA analysis during multimodality treatment of locally advanced rectal cancer: A prospective biomarker study.
2019
https://dx.doi.org/10.1136/gutjnl-2017-315852
N.B. These documents automatically identified may not have been verified by the study sponsor.
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