NCT05446545Recruiting
Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer
Evaluation of Prognostic and Predictive Values of Bespoke Circulating Tumor DNA Assay for Recurrent and Response Monitoring in Patients With Advanced Epithelial Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 28 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 139 (estimated)
- First submitted
- 13 Apr 2022
- Start date
- 1 Sept 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Fudan University
- Diseases
- Ovarian cancer
- NCT number
- NCT05446545
What you commit to
- Study type: Observational
- Planned participants: 139
- From 1 Sept 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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);
Other
- Patients in pregnancy;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hao Wen Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.