Ovarian CancerNCT03691012
Circulating Tumour DNA as a Marker of Residual Disease & Response to Adjuvant Chemotherapy in Stage I-IV Ovarian Cancer
An observational study of Ovarian Cancer, run by Walter and Eliza Hall Institute of Medical Research at 7 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Circulating tumour DNA testing
- How many people
- 118 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 May 2017to 9 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available.
- Fit and planned for adjuvant chemotherapy
Who cannot join
- History of another primary cancer within the last 3 years
- Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC) of mucinous subtype and sarcoma
- Patients with Stage IV disease who have residual disease
- Patients <18 years
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Epworth Freemasons
Melbourne, Victoria, 3002
Western Hospital
Melbourne, Victoria, 3021
Mercy Hospital for Women
Melbourne, Victoria, 3084
Cabrini Malvern
Melbourne, Victoria, 3144
Monash Medical Centre
Melbourne, Victoria, 3168
United States1 site
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official 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)
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)
Read the detailed description
This is a prospective,multi-centre study involving serial blood collections from 100 stage I-IV debulked (or to be debulked in the case of neoadjuvant chemotherapy) high grade serous, endometrioid and clear cell ovarian, fallopian tube and primary peritoneal cancer patients (EOC) or ovarian carcinosarcoma planned to receive adjuvant chemotherapy. Tumour samples will be made available following patient enrollment for the primary debulking group, and following surgery for the neoadjuvant group for mutation analysis. Ascites will not be accepted. Up to four blood samples in the primary debulking group and up to five blood samples in the neoadjuvant group will be collected from each patient over a 6-8 month period for ctDNA and Ca125 analysis Choice of chemotherapy will be platinum based treatment at the treating clinician's discretion as per standard of care.
- Conditions
- Ovarian Cancer
- Being tested
- Circulating tumour DNA testing
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumour DNA testingDiagnostic test
Circulating tumour DNA testing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
polymerase chain reaction (PCR) to quantify ctDNA
Measured: 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 outcomes (5)
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.
polymerase chain reaction (PCR) to quantify ctDNA
Measured: 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)
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.
polymerase chain reaction (PCR) to quantify ctDNA
Measured: 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).
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
polymerase chain reaction (PCR) to quantify ctDNA
Measured: 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)
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.
polymerase chain reaction (PCR) to quantify ctDNA
Measured: At the completion of 6 of chemotherapy (primary debulking group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)
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.
polymerase chain reaction (PCR) to quantify ctDNA
Measured: At the completion of 6 cycles of chemotherapy (neoadjuvant group) confirmed with conventional radiology and CA125 (at the end of 18 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start9 May 2017
- Primary completion31 Dec 2020
- Study completion9 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter and Eliza Hall Institute of Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Maria Edmonds, Walter and Eliza Hall Institute of Medical Research
- Investigators
- Sumitra Ananda, Associate Professor, Principal investigator, Walter and ELiza Hall Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691012
- Sponsor's protocol ID
- WEHI-ctDNA-10
- Status last verified
- May 2023
- First submitted
- 11 Mar 2018
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients will be provided with a unique code number for the purposes of transferring information. Any data that leave the hospital will be coded. this information does not include patient's name or other personal identifiers
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03691012
- Acronym / sponsor ID
- WEHI-ctDNA-10
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Walter and Eliza Hall Institute of Medical ResearchUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 9 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 9 May 2025 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This is a prospective,multi-centre study involving serial blood collections from 100 stage I-IV debulked (or to be debulked in the case of neoadjuvant chemotherapy) high grade serous, endometrioid and clear cell ovarian, fallopian tube and primary peritoneal cancer patients (EOC) or ovarian carcinosarcoma planned to receive adjuvant chemotherapy. Tumour samples will be made available following patient enrollment for the primary debulking group, and following surgery for the neoadjuvant group for mutation analysis. Ascites will not be accepted. Up to four blood samples in the primary debulking group and up to five blood samples in the neoadjuvant group will be collected from each patient over a 6-8 month period for ctDNA and Ca125 analysis Choice of chemotherapy will be platinum based treatment at the treating clinician's discretion as per standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
- A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available.
- Fit and planned for adjuvant chemotherapy
Key exclusion criteria (4 listed)
- History of another primary cancer within the last 3 years
- Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC) of mucinous subtype and sarcoma
- Patients with Stage IV disease who have residual disease
- Patients <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumour DNA testingCirculating tumour DNA testing | Diagnostic test | – |
Primary outcome
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.
Time frame: 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).
polymerase chain reaction (PCR) to quantify ctDNA
5 secondary outcomes
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.
Time frame: 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)
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.
Time frame: 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).
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
Time frame: 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)
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.
Time frame: At the completion of 6 of chemotherapy (primary debulking group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)
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.
Time frame: At the completion of 6 cycles of chemotherapy (neoadjuvant group) confirmed with conventional radiology and CA125 (at the end of 18 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. All patients will be provided with a unique code number for the purposes of transferring information. Any data that leave the hospital will be coded. this information does not include patient's name or other personal identifiers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumitra Ananda, Associate Professor principal investigator
Walter and ELiza Hall Institute
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Walter and Eliza Hall Institute of Medical Research at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.