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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03691012




Registration number
NCT03691012
Ethics application status
Date submitted
11/03/2018
Date registered
1/10/2018
Date last updated
9/05/2023

Titles & IDs
Public title
Circulating Tumour DNA as a Marker of Residual Disease & Response to Adjuvant Chemotherapy in Stage I-IV 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] 0 0
WEHI-ctDNA-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Circulating tumour DNA testing

Diagnosis / Prognosis: Circulating tumour DNA testing
Circulating tumour DNA testing
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells,can be used as highly specific biomarkers of disease burden. Baseline.
Timepoint [1] 0 0
After surgery (primary debulking group) or pre cycle 1 of therapy (neoadjuvant) confirmed with conventional radiological imaging and CA125 (cycles of chemotherapy are 21 days in length).
Secondary outcome [1] 0 0
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.
Timepoint [1] 0 0
At the completion of pre cycle 3 of chemotherapy (primary debulking group) confirmed with Convential Radiological imaging and CA125. (each cycle 21 days in length)
Secondary outcome [2] 0 0
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.
Timepoint [2] 0 0
circulating tumour DNA (ctDNA) during chemotherapy pre cycle 5 confirmed (primary debluking group) with conventional Radiological imaging and CA125 (each cycle 21 days in length).
Secondary outcome [3] 0 0
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result
Timepoint [3] 0 0
circulating tumour DNA (ctDNA) during chemotherapy pre cycle 3 or 4 (neoadjuvant group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)
Secondary outcome [4] 0 0
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.
Timepoint [4] 0 0
At the completion of 6 of chemotherapy (primary debulking group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)
Secondary outcome [5] 0 0
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.
Timepoint [5] 0 0
At the completion of 6 cycles of chemotherapy (neoadjuvant group) confirmed with conventional radiology and CA125 (at the end of 18 weeks).

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
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of another primary cancer within the last 3 years

2. Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (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
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/05/2025
Actual
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Epworth Freemasons - Melbourne
Recruitment hospital [3] 0 0
Western Hospital - Melbourne
Recruitment hospital [4] 0 0
Mercy Hospital for Women - Melbourne
Recruitment hospital [5] 0 0
Cabrini Malvern - Melbourne
Recruitment hospital [6] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 0 0
3021 - Melbourne
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment postcode(s) [5] 0 0
3144 - Melbourne
Recruitment postcode(s) [6] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Johns Hopkins University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate that detectable ctDNA in peripheral blood following debulking of the primary
tumour or following completion of adjuvant treatment for is associated with subsequent
disease recurrence in stage I-IV epithelial, fallopian tube and primary peritoneal cancer
(Ovarian Cancer)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03691012
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sumitra Ananda, Associate Professor
Address 0 0
Walter and ELiza Hall Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03691012