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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12617001119381
Ethics application status
Approved
Date submitted
20/07/2017
Date registered
31/07/2017
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Circulating Tumour DNA in Stage 1 to 4 Ovarian Cancer
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Scientific title
Circulating Tumour DNA as a Marker of Residual Disease and Response to Adjuvant Chemotherapy in Stage I - IV Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC)
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Secondary ID [1]
292484
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WEHI-ctDNA-10
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Universal Trial Number (UTN)
U1111-1199-5975
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Trial acronym
DYNAMIC-Ovarian
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer
304109
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Condition category
Condition code
Cancer
303441
303441
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0
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
Study involves serial blood collections in patients with stage I-IV epithelial or carcinosarcoma ovarian cancer who have undergone surgery (or will have interim debulking in the case of neoadjuvant chemotherapy) and are planned to receive adjuvant chemotherapy. Four to five blood samples will be collected from each patient over a 6-8 month period for circulating tumour DNA (ctDNA) and Ca125 analysis. Following completion of chemotherapy the patient will be followed up every three months with blood test for Ca125 for the first two years then followed as per clinician's discretion for survival information.
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Intervention code [1]
298663
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
302820
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Association between ctDNA detection in peripheral blood with disease recurrence, as assessed by review of medical records.
Disease recurrence is assessed by medical review of symptoms, standard CA125 blood tests with or without a CT scan
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Assessment method [1]
302820
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Timepoint [1]
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ctDNA samples are collected at 4 or 5 time points only; prior to commencing the first cycle of chemotherapy then 2-3 times during their course of chemotherapy and finally 6-8 weeks following completion of chemotherapy. Disease recurrence is then assessed for up to a maximum of 4 years; initially every 3 months for the first 2 years that at intervals at the discretion of the treating clinician.
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Secondary outcome [1]
337164
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Association between presence of detectable ctDNA and time to disease recurrence.
Recurrence is assessed by medical review of symptoms, standard CA125 blood test with or without a CT scan.
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Assessment method [1]
337164
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Timepoint [1]
337164
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Disease recurrence is assessed for up to a maximum of 4 years following completion of chemotherapy; initially every 3 months for the first 2 years that at intervals at the discretion of the treating clinician.
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Eligibility
Key inclusion criteria
1. Patients that have had primary debulking surgery for curatively resected stage I-IV high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Stage IV patients can only be included in the study if they have had a complete resection of all macroscopic disease with no residual disease.
OR
Patients commencing neoadjuvant chemotherapy for stage I-
III high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Women must be planned to undergo interim debulking surgery.
2. A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available.
3. Fit and planned for adjuvant chemotherapy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
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 3 years,
with the exception of non-melanomatous skin cancer,
carcinoma in situ of the cervix and fully resected stage1a
endometrial cancer
2. Patients with EOC of mucinous subtype and sarcoma
3. Patients with Stage IV disease who have residual disease
4. Patients <18 years
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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
Recruiting
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Date of first participant enrolment
Anticipated
31/07/2017
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Actual
8/08/2017
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Date of last participant enrolment
Anticipated
30/06/2020
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Actual
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Date of last data collection
Anticipated
30/06/2023
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Actual
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Sample size
Target
100
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Accrual to date
53
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
12242
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
12243
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Sunshine Hospital - St Albans
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Recruitment hospital [3]
12244
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Cabrini Hospital - Malvern - Malvern
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Recruitment hospital [4]
12245
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Monash Medical Centre - Moorabbin campus - East Bentleigh
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Recruitment hospital [5]
12246
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Epworth Freemasons - Melbourne
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Recruitment hospital [6]
12247
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The Royal Women's Hospital - Parkville
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Recruitment hospital [7]
12248
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Mercy Hospital for Women - Heidelberg
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Recruitment hospital [8]
14648
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Newcastle Private Hospital - New Lambton Heights
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Recruitment hospital [9]
14649
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Border Medical Oncology - Albury
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Recruitment postcode(s) [1]
27672
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
27673
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2640 - Albury
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Recruitment postcode(s) [3]
24428
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3000 - Melbourne
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Recruitment postcode(s) [4]
24432
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3002 - Melbourne
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Recruitment postcode(s) [5]
24429
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3021 - St Albans
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Recruitment postcode(s) [6]
24433
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3052 - Parkville
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Recruitment postcode(s) [7]
24434
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3084 - Heidelberg
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Recruitment postcode(s) [8]
24430
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3144 - Malvern
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Recruitment postcode(s) [9]
24431
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3165 - East Bentleigh
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Recruitment outside Australia
Country [1]
20856
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United States of America
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State/province [1]
20856
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Baltimore
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Funding & Sponsors
Funding source category [1]
297053
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Charities/Societies/Foundations
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Name [1]
297053
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Marcus Foundation
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Address [1]
297053
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1G Royal Parade, Parkville VIC 3052
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Country [1]
297053
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Australia
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Primary sponsor type
Other
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Name
Walter and Eliza Hall Institute of Medical Research
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Address
1G Royal Parade, Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
296057
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None
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Name [1]
296057
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Address [1]
296057
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Country [1]
296057
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298235
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Melbourne Health
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Ethics committee address [1]
298235
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Royal Melbourne Hospital Flemington Rd, Parkville VIC 3050
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Ethics committee country [1]
298235
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Australia
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Date submitted for ethics approval [1]
298235
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29/03/2017
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Approval date [1]
298235
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09/05/2017
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Ethics approval number [1]
298235
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HREC/17/MH/108
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Summary
Brief summary
The primary purpose of this study is to evaluate whether the presence of circulating tumour DNA (ctDNA) in a patient's blood following surgery or chemotherapy for ovarian cancer, is associated with cancer recurrence. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have stage I-IV curatively resected high grade serous, endometrioid and clear cell ovarian, fallopian tube or primary peritoneal cancer or ovarian carcinosarcoma for which you are scheduled to commence neoadjuvant or adjuvant chemotherapy. All patients enrolled in this study will have up to five blood samples collected over 6-8 months, followed by a clinical follow up every 3 months for 2 years following completion of chemotherapy. Your treating clinician may also decide to continue with further follow-up. It is hoped that the findings from this trial will demonstrate an association between ctDNA detection in the patients blood following surgery and chemotherapy, with ovarian cancer recurrence. This would allow real-time testing of the benefit of adjuvant chemotherapy by assessing ctDNA.
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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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A/Prof Sumitra Ananda
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Address
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Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
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Country
76430
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Australia
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Phone
76430
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+61 3 8559 5000
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Fax
76430
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Email
76430
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sumitra.ananda@petermac.org
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Contact person for public queries
Name
76431
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Nicole Ng
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Address
76431
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WEHI
1G Royal Parade, Parkville VIC 3052
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Country
76431
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Australia
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Phone
76431
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+61 3 9345 2880
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Fax
76431
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+61393452317
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Email
76431
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dynamic-ovarian@mh.org.au
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Contact person for scientific queries
Name
76432
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Sumitra Ananda
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Address
76432
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Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
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Country
76432
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Australia
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Phone
76432
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+61 3 8559 5000
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Fax
76432
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Email
76432
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sumitra.ananda@petermac.org
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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