Ovarian CancerEOCNCT05446545
Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer
An observational study of Ovarian Cancer, run by Fudan University at 1 site in China.
Trial summary
This prospective observational study is to assess the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer (EOC) undergoing surgery, adjuvant chemotherapy, followed by poly adenosine diphosphate-ribose polymerase (PARP) inhibitors until disease progression or the end of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- ND-EOC or platinum-sensitive rEOC
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed advanced EOC patients who are eligible for radical surgery or relapsed EOC patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery.
Who may be able to join
- Female, over 18 years of age;
- Patients with advanced epithelial ovarian cancer who are eligible for radical surgery;
- Patients with advanced epithelial ovarian cancer relapsed from platinum-based therapies and eligible for secondary cytoreductive surgery;
- The subjects agree to sign the informed consent and agree to use their samples and data for related scientific research;
- Subjects agree to collect tissue samples and peripheral blood samples for whole exon sequencing and ctDNA monitoring.
Who cannot join
- Patients who are diagnosed, tested or treated for cancer other than ovarian cancer within 2 years (except for basal skin or squamous cell cancer that has been definitively treated);
- Patients in pregnancy;
- Patients with a history of blood transfusion within 3 months before enrollment;
- Newly diagnosed patients who only received laparoscopic surgery;
- Patients received chemotherapy or other anti-tumor therapy before surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hao Wen
Shanghai, Shanghai Municipality, 200023
Hao Wen, Dr, +862164175590 ext. 81000, wenhao@shca.org.cn
About this study
Official title: Evaluation of Prognostic and Predictive Values of Bespoke Circulating Tumor DNA Assay for Recurrent and Response Monitoring in Patients With Advanced Epithelial Ovarian Cancer
This prospective observational study is to assess the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer (EOC) undergoing surgery, adjuvant chemotherapy, followed by poly adenosine diphosphate-ribose polymerase (PARP) inhibitors until disease progression or the end of the study. All patients will be closely monitored throughout the course of disease by a tumor-informed bespoke ctDNA assay as well as traditional methods of surveillance, such as CA125 and imaging. This study may provide preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.
Read the detailed description
This observational study is designed for exploring prognostic and predictive values of the tumor-informed bespoke ctDNA assay in advanced EOC. Newly diagnosed patients who are eligible for radical surgery or relapsed patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery will be enrolled. The patients will be treated with SOC adjuvant therapies followed by PARP inhibitor for maintenance.
To evaluate ctDNA dynamics, tumor tissue collected from surgery will be sequenced with whole-exome sequencing (WES) to design patient-specific 16-plex panel. At planned monitoring timepoints, blood samples will be drawn, and ctDNA will be sequenced with ultra-deep ctDNA high-throughput sequencing methods.
Traditional surveillance methods will be applied as comparison, including but not limited to carbohydrate antigen 125 (CA-125)/ human epididymal protein 4 (HE4)/ carcinoembryonic antigen (CEA)/ carbohydrate antigen 199 (CA199), etc., as well as standard imaging.
Survival analyses will be conducted based on ctDNA status (positive/negative) after surgery. Recurrence rate of each subgroup, positive predictive values and negative predictive values etc. will be examined. Changes in ctDNA levels (ΔctDNA) during treatment will be used to evaluate the efficacy of maintenance therapy comparing traditional biomarkers,
- Conditions
- Ovarian Cancer
- Being tested
- ND-EOC or platinum-sensitive rEOC
- Keywords
- Ovarian cancer, personalized ctDNA assay, treatment response monitoring, recurrence monitoring, PARPi
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND-EOC or platinum-sensitive rEOCOther
platinum-based combined chemotherapy or bevacizumab will be used for adjuvant treatment, followed by maintenance therapy with poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, or bevacizumab, or other anti-tumor angiogenesis drugs or immune checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| ND-EOC or platinum-sensitive rEOC | 1. Newly diagnosed patients with advanced EOC (ND-EOC) who are eligible for radical surgery.
2. Patients relapsed from platinum-based therapy (rEOC) who are eligible for secondary cytoreductive surgery. Receives: Other: ND-EOC or platinum-sensitive rEOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Determine PFS in ctDNA positive versus ctDNA negative groups.
Measured: Two years
Secondary outcomes (1)
Overall Survival (OS)
Determine OS in ctDNA positive versus ctDNA negative groups.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- BGI Tianjin
- Responsible party
- Principal investigator, Zhong Zheng MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446545
- Sponsor's protocol ID
- 2021-39-2342
- Acronym
- EOC
- Status last verified
- Dec 2023
- First submitted
- 13 Apr 2022
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic and Predictive Values of Bespoke Circulating Tumor DNA Assay for Recurrent and Response Monitoring in Patients With Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05446545
- Acronym / sponsor ID
- EOC / 2021-39-2342
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, personalized ctDNA assay, treatment response monitoring, recurrence monitoring, PARPi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- BGI Tianjin
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 2022 (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.
This prospective observational study is to assess the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer (EOC) undergoing surgery, adjuvant chemotherapy, followed by poly adenosine diphosphate-ribose polymerase (PARP) inhibitors until disease progression or the end of the study. All patients will be closely monitored throughout the course of disease by a tumor-informed bespoke ctDNA assay as well as traditional methods of surveillance, such as CA125 and imaging. This study may provide preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.
Detailed description
This observational study is designed for exploring prognostic and predictive values of the tumor-informed bespoke ctDNA assay in advanced EOC. Newly diagnosed patients who are eligible for radical surgery or relapsed patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery will be enrolled. The patients will be treated with SOC adjuvant therapies followed by PARP inhibitor for maintenance.
To evaluate ctDNA dynamics, tumor tissue collected from surgery will be sequenced with whole-exome sequencing (WES) to design patient-specific 16-plex panel. At planned monitoring timepoints, blood samples will be drawn, and ctDNA will be sequenced with ultra-deep ctDNA high-throughput sequencing methods.
Traditional surveillance methods will be applied as comparison, including but not limited to carbohydrate antigen 125 (CA-125)/ human epididymal protein 4 (HE4)/ carcinoembryonic antigen (CEA)/ carbohydrate antigen 199 (CA199), etc., as well as standard imaging.
Survival analyses will be conducted based on ctDNA status (positive/negative) after surgery. Recurrence rate of each subgroup, positive predictive values and negative predictive values etc. will be examined. Changes in ctDNA levels (ΔctDNA) during treatment will be used to evaluate the efficacy of maintenance therapy comparing traditional biomarkers,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ND-EOC or platinum-sensitive rEOC | – | Other: ND-EOC or platinum-sensitive rEOC1. Newly diagnosed patients with advanced EOC (ND-EOC) who are eligible for radical surgery. 2. Patients relapsed from platinum-based therapy (rEOC) who are eligible for secondary cytoreductive surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed advanced EOC patients who are eligible for radical surgery or relapsed EOC patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery.
Key inclusion criteria (5 listed)
- Female, over 18 years of age;
- Patients with advanced epithelial ovarian cancer who are eligible for radical surgery;
- Patients with advanced epithelial ovarian cancer relapsed from platinum-based therapies and eligible for secondary cytoreductive surgery;
- The subjects agree to sign the informed consent and agree to use their samples and data for related scientific research;
- Subjects agree to collect tissue samples and peripheral blood samples for whole exon sequencing and ctDNA monitoring.
Key exclusion criteria (5 listed)
- Patients who are diagnosed, tested or treated for cancer other than ovarian cancer within 2 years (except for basal skin or squamous cell cancer that has been definitively treated);
- Patients in pregnancy;
- Patients with a history of blood transfusion within 3 months before enrollment;
- Newly diagnosed patients who only received laparoscopic surgery;
- Patients received chemotherapy or other anti-tumor therapy before surgery.
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 |
|---|---|---|
| ND-EOC or platinum-sensitive rEOCplatinum-based combined chemotherapy or bevacizumab will be used for adjuvant treatment, followed by maintenance therapy with poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, or bevacizumab, or other anti-tumor angiogenesis drugs or immune checkpoint inhibitors | Other | ND-EOC or platinum-sensitive rEOC |
Primary outcome
Progression free survival (PFS)
Time frame: Two years
Determine PFS in ctDNA positive versus ctDNA negative groups.
1 secondary outcome
Overall Survival (OS)
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fudan University at 1 site in China.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Wen, MD (+86-021-64175590 ext. 81000, wenhao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Two years). 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 28 Dec 2023.