Ovarian Cancer Stage IVNCT06025045
Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments
An observational study of Ovarian Cancer Stage IV and Ovarian Cancer Stage III, run by Jing Li at 1 site in China.
Trial summary
Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Stage IV, Ovarian Cancer Stage III
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Advanced ovarian cancer patients
Who may be able to join
- ≥ 18 years old.
- Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
- The participant has read and fully understands the patient information, and has signed the informed consent form.
- The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -
Who cannot join
- Other tumors have been detected within the last 5 years.
- Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
- Patients was deemed unsuitable to participate in this study by other researchers.
- Patients who have previously received neoadjuvant chemotherapy or targeted therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong
Jing Li, Professor, 15915893493, lijing228@mail.sysu.edu.cn
About this study
Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.
Read the detailed description
This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.
- Conditions
- Ovarian Cancer Stage IV, Ovarian Cancer Stage III
- Keywords
- ctDNA, Ovarian cancer, PDS, IDS, adjuvant chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years DFS rate
The recurrence rate of patients at two years after surgery
Measured: 2 years
Secondary outcomes (1)
DFS
Disease-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer Stage IVStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Li
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Shihejiyin Technology, Inc.
- Responsible party
- Sponsor-investigator, Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025045
- Sponsor's protocol ID
- SunYatsen202309
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments
- ClinicalTrials.gov ID
- NCT06025045
- Acronym / sponsor ID
- SunYatsen202309
- Conditions
- Ovarian Cancer Stage IV, Ovarian Cancer Stage III
- Keywords
- ctDNA, Ovarian cancer, PDS, IDS, adjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jing LiUniversity, hospital or other
- Collaborators
- Nanjing Shihejiyin Technology, Inc.
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 Sep 2023 (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.
Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.
Detailed description
This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced ovarian cancer patients
Key inclusion criteria (4 listed)
- ≥ 18 years old.
- Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
- The participant has read and fully understands the patient information, and has signed the informed consent form.
- The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -
Key exclusion criteria (4 listed)
- Other tumors have been detected within the last 5 years.
- Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
- Patients was deemed unsuitable to participate in this study by other researchers.
- Patients who have previously received neoadjuvant chemotherapy or targeted therapy.
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
2 years DFS rate
Time frame: 2 years
The recurrence rate of patients at two years after surgery
1 secondary outcome
DFS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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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.
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 Stage IV and Ovarian Cancer Stage III, run by Jing Li 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 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 6 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Li, Prefessor (15915893493, lijing228@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 years DFS rate (time frame: 2 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 6 Sep 2023.