Ovarian CancerNCT05976932
Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer
An observational study of Ovarian Cancer, run by Fudan University.
Trial summary
This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- pegylated liposomal doxorubicin
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Oct 2024
- 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: platinum-resistant ovarian cancer
Who may be able to join
- Female, over 18 years of age;
- Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
- pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
- ECOG≤ 2;
- Expected survival time ≥3 months;
- The subjects were able to understand the study process and voluntarily joined the study.
Who cannot join
- Pregnant and lactating patients;
- Patients with severe or uncontrolled infections;
- Patients who are allergic or intolerant to the investigational drug;
- Patients who are enrolled in or within a month of another clinical trial.
Trial locations and contacts
No sites are listed yet.
Xiaohua Wu, MD contact
About this study
Official title: The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
Read the detailed description
The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study.
After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS).
Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- pegylated liposomal doxorubicin
- Keywords
- ctDNA, pegylated liposomal doxorubicin, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicinDrug
Also called PLD
All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment. Receives: Drug: pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the consistency of circulating tumor DNA with CT scan
measuring the mutations of TP53，reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes，calculating Kappa value，and conducting a intrarater reliability
Measured: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionOct 2024 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976932
- Sponsor's protocol ID
- 2210263-1
- Status last verified
- Aug 2023
- First submitted
- 30 Jun 2023
- Last updated
- 4 Aug 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05976932
- Acronym / sponsor ID
- 2210263-1
- Conditions
- Ovarian Cancer
- Keywords
- ctDNA, pegylated liposomal doxorubicin, ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 Aug 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.
This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
Detailed description
The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study.
After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS).
Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | Drug: pegylated liposomal doxorubicinAfter enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- platinum-resistant ovarian cancer
Key inclusion criteria (6 listed)
- Female, over 18 years of age;
- Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
- pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
- ECOG≤ 2;
- Expected survival time ≥3 months;
Key exclusion criteria (4 listed)
- Pregnant and lactating patients;
- Patients with severe or uncontrolled infections;
- Patients who are allergic or intolerant to the investigational drug;
- Patients who are enrolled in or within a month of another clinical trial.
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 |
|---|---|---|
| pegylated liposomal doxorubicinAlso: PLDAll eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy. | Drug | treatment group |
Primary outcome
the consistency of circulating tumor DNA with CT scan
Time frame: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
measuring the mutations of TP53，reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes，calculating Kappa value，and conducting a intrarater reliability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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. This study is not recruiting at the moment.
Xiaohua Wu, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fudan University.
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 6 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 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?
the consistency of circulating tumor DNA with CT scan (time frame: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）). 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 4 Aug 2023.