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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Circulating Tumour DNA in Stage 1 to 4 Ovarian Cancer
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)
Secondary ID [1] 292484 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer 304109 0
Condition category
Condition code
Cancer 303441 303441 0 0
Ovarian and primary peritoneal

Study type
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 298663 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group

Primary outcome [1] 302820 0
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
Timepoint [1] 302820 0
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.
Secondary outcome [1] 337164 0
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.

Timepoint [1] 337164 0
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.

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.
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.
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
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

Study design
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 12242 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 12243 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 12244 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 12245 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [5] 12246 0
Epworth Freemasons - Melbourne
Recruitment hospital [6] 12247 0
The Royal Women's Hospital - Parkville
Recruitment hospital [7] 12248 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [8] 14648 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [9] 14649 0
Border Medical Oncology - Albury
Recruitment postcode(s) [1] 27672 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 27673 0
2640 - Albury
Recruitment postcode(s) [3] 24428 0
3000 - Melbourne
Recruitment postcode(s) [4] 24432 0
3002 - Melbourne
Recruitment postcode(s) [5] 24429 0
3021 - St Albans
Recruitment postcode(s) [6] 24433 0
3052 - Parkville
Recruitment postcode(s) [7] 24434 0
3084 - Heidelberg
Recruitment postcode(s) [8] 24430 0
3144 - Malvern
Recruitment postcode(s) [9] 24431 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 20856 0
United States of America
State/province [1] 20856 0

Funding & Sponsors
Funding source category [1] 297053 0
Name [1] 297053 0
Marcus Foundation
Country [1] 297053 0
Primary sponsor type
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville VIC 3052
Secondary sponsor category [1] 296057 0
Name [1] 296057 0
Address [1] 296057 0
Country [1] 296057 0

Ethics approval
Ethics application status
Ethics committee name [1] 298235 0
Melbourne Health
Ethics committee address [1] 298235 0
Royal Melbourne Hospital
Flemington Rd, Parkville VIC 3050
Ethics committee country [1] 298235 0
Date submitted for ethics approval [1] 298235 0
Approval date [1] 298235 0
Ethics approval number [1] 298235 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 76430 0
A/Prof Sumitra Ananda
Address 76430 0
Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
Country 76430 0
Phone 76430 0
+61 3 8559 5000
Fax 76430 0
Email 76430 0
Contact person for public queries
Name 76431 0
Ms Nicole Ng
Address 76431 0
1G Royal Parade, Parkville VIC 3052
Country 76431 0
Phone 76431 0
+61 3 9345 2880
Fax 76431 0
Email 76431 0
Contact person for scientific queries
Name 76432 0
Dr Sumitra Ananda
Address 76432 0
Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
Country 76432 0
Phone 76432 0
+61 3 8559 5000
Fax 76432 0
Email 76432 0

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

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.