High-grade Serous Ovarian CancerNCT05027828
CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer
An observational study of High-grade Serous Ovarian Cancer and Circulating Tumor DNA, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High-grade Serous Ovarian Cancer, Circulating Tumor DNA
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Sep 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newly-diagnosed and treated patients with high-grade serous ovarian cancer who will receive PARP inhibitors as first-line maintenance therapy after surgery and traditional chemotherapy.
Who may be able to join
- Ovarian cancer first diagnosed and treated;
- Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
- The stage of the disease is II-IV, and surgery will be performed after evaluation;
- Age ≥ 18 years old;
- Subjects and their families fully understand the research plan and sign an informed consent form.
Who cannot join
- Pathologically confirmed as non-epithelial ovarian cancer;
- Surgical treatment cannot be performed after evaluation;
- Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
- Patients who do not agree to use clinical first-line targeted drugs;
- Severe mental illness;
- Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.
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
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Xipeng Wang, Dr, 25078999, steveoizzie@icloud.com
About this study
Official title: Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients using olaparib only | Not described | |
| patients using olaparib combined with bevacizumab | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.
Measured: about 36 months after using PARP inhibitors
Secondary outcomes (2)
Overall survival
Measured: about over 5 years after using PARP inhibitors
Objective response rate
To evaluate the general response of patients with ovarian cancer to PARP inhibitors
Measured: 36 months after using PARP inhibitors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Serous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027828
- Sponsor's protocol ID
- XH-21-008
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05027828
- Acronym / sponsor ID
- XH-21-008
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Aug 2021 (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 study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients using olaparib only | – | – |
| patients using olaparib combined with bevacizumab | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly-diagnosed and treated patients with high-grade serous ovarian cancer who will receive PARP inhibitors as first-line maintenance therapy after surgery and traditional chemotherapy.
Key inclusion criteria (5 listed)
- Ovarian cancer first diagnosed and treated;
- Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
- The stage of the disease is II-IV, and surgery will be performed after evaluation;
- Age ≥ 18 years old;
- Subjects and their families fully understand the research plan and sign an informed consent form.
Key exclusion criteria (6 listed)
- Pathologically confirmed as non-epithelial ovarian cancer;
- Surgical treatment cannot be performed after evaluation;
- Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
- Patients who do not agree to use clinical first-line targeted drugs;
- Severe mental illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: about 36 months after using PARP inhibitors
To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.
2 secondary outcomes
Overall survival
Time frame: about over 5 years after using PARP inhibitors
Objective response rate
Time frame: 36 months after using PARP inhibitors
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 24 Apr 2026.
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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.
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
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 High-grade Serous Ovarian Cancer and Circulating Tumor DNA, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 6 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 24 Apr 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: about 36 months after using PARP inhibitors). 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 24 Apr 2026.