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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
23/10/2018
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
WEHI-ctDNA-10
Universal Trial Number (UTN)
U1111-1199-5975
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

Intervention/exposure
Study type
Observational
Patient registry
False
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
Uncontrolled

Outcomes
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.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

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] 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 postcode(s) [1] 24428 0
3000 - Melbourne
Recruitment postcode(s) [2] 24429 0
3021 - St Albans
Recruitment postcode(s) [3] 24430 0
3144 - Malvern
Recruitment postcode(s) [4] 24431 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 24432 0
3002 - Melbourne
Recruitment postcode(s) [6] 24433 0
3052 - Parkville
Recruitment postcode(s) [7] 24434 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 20856 0
United States of America
State/province [1] 20856 0
Baltimore

Funding & Sponsors
Funding source category [1] 297053 0
Charities/Societies/Foundations
Name [1] 297053 0
Marcus Foundation
Address [1] 297053 0
1G Royal Parade, Parkville VIC 3052
Country [1] 297053 0
Australia
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Parade, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 296057 0
None
Name [1] 296057 0
Address [1] 296057 0
Country [1] 296057 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 298235 0
29/03/2017
Approval date [1] 298235 0
09/05/2017
Ethics approval number [1] 298235 0
HREC/17/MH/108

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 optimally debulked 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

Contacts
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
Australia
Phone 76430 0
+61 3 8559 5000
Fax 76430 0
Email 76430 0
sumitra.ananda@petermac.org
Contact person for public queries
Name 76431 0
Ms Nicole Ng
Address 76431 0
WEHI
1G Royal Parade, Parkville VIC 3052
Country 76431 0
Australia
Phone 76431 0
+61 3 9345 2880
Fax 76431 0
+61393452317
Email 76431 0
dynamic-ovarian@mh.org.au
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
Australia
Phone 76432 0
+61 3 8559 5000
Fax 76432 0
Email 76432 0
sumitra.ananda@petermac.org

No information has been provided regarding IPD availability
Summary results
No Results