Ovarian CancerNCT05504174
Detection of Circulating Tumor DNA Through Liquid Biopsies in Ovarian Cancer Patients and Evaluation of Prognostic and Predictive Values of Circulating Tumor DNA Assay.
An observational study of Ovarian Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Ovarian cancer is the eighth most common cancer in women in Korea, with 2,600 cases occurring annually, and the number of cases is steadily increasing. There is no practical method for early detection of ovarian cancer, and 75 percent of patients are diagnosed with advanced stage. Read more about this study
- Who is it for?
- Ages 19 to 95 years, men only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2019to 30 Jun 2022
- 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 19 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients, with epithelial ovarian cancer and patients with benign adnexal disease with serum CA-125 >35 U/mL
Who may be able to join
- Female, over 19 years of age;
- Patients with epithelial ovarian cancer
- Patients with Serum CA-125 >35 U/mL
Who cannot join
- Patients in pregnancy
- Patients being treated for cancer of other organs, including gynecological cancer.
- Patients who has difficulty reading and understanding Korean.
- The tester's determination that the patient will not be able to comply with the clinical trial procedures.
- Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Ovarian cancer is the eighth most common cancer in women in Korea, with 2,600 cases occurring annually, and the number of cases is steadily increasing. There is no practical method for early detection of ovarian cancer, and 75 percent of patients are diagnosed with advanced stage. The treatment of ovarian cancer is based on surgical removal and platinum-based chemotherapy. The cell-free DNA (cfDNA) test has the advantage of being able to track and monitor mutations of tumor origin noninvasive.
The objective of this study was to assess the feasibility of circulating tumor DNA (ctDNA) as a biomarker for cancer recurrence in ovarian cancer after surgery. Diagnosis and prognosis evaluation using conventional methods such as CA-125, radiologic examination (CT), had limitations in diagnosing and prognostic observation of ovarian cancer. For precise diagnostic purposes, CA-125 had limitations because it was detected as positive value when the tumor size is enough large or states of metastasis, and CT-based diagnosis is practicable only when the size of tumor is detectable.
Read more
However, cell-free DNA can be detected even if the tumor size is small because it detects very small amount of mutation gene in the blood. In addition, the detection of tumor cell DNA from circulating blood can be a clinical decision making point whether to continue or stop chemotherapy.
In this study, the investigators collect whole blood from patients with ovarian cancer undergoing surgery. Control samples will be obtained from patients undergoing surgery for benign adnexal disease with CA125 >35U/ml. In ovarian cancer patients, blood samples will be collected prospectively every 3 months after surgery. Mutations found at the initial sample will be monitored during chemotherapy to investigate the ctDNA pattern. The primary outcome will be progression free survival (PFS).
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer group | Patients pathologically diagnosed with ovarian cancer | |
| Control group | Patients with benign or borderline adnexal mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Determine Progression free survival (PFS) according to ctDNA pattern at time of surgery
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 posted17 Aug 2022
- Study start10 Sep 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Yonsei 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Yun LEE, M.D., Principal investigator, Department of Obstetrics and Gynecology, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504174
- Sponsor's protocol ID
- 4-2019-0698
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 26 Aug 2022
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Tumor DNA Through Liquid Biopsies in Ovarian Cancer Patients and Evaluation of Prognostic and Predictive Values of Circulating Tumor DNA Assay.
- ClinicalTrials.gov ID
- NCT05504174
- Acronym / sponsor ID
- 4-2019-0698
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Aug 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.
Ovarian cancer is the eighth most common cancer in women in Korea, with 2,600 cases occurring annually, and the number of cases is steadily increasing. There is no practical method for early detection of ovarian cancer, and 75 percent of patients are diagnosed with advanced stage. The treatment of ovarian cancer is based on surgical removal and platinum-based chemotherapy. The cell-free DNA (cfDNA) test has the advantage of being able to track and monitor mutations of tumor origin noninvasive.
The objective of this study was to assess the feasibility of circulating tumor DNA (ctDNA) as a biomarker for cancer recurrence in ovarian cancer after surgery. Diagnosis and prognosis evaluation using conventional methods such as CA-125, radiologic examination (CT), had limitations in diagnosing and prognostic observation of ovarian cancer. For precise diagnostic purposes, CA-125 had limitations because it was detected as positive value when the tumor size is enough large or states of metastasis, and CT-based diagnosis is practicable only when the size of tumor is detectable.
However, cell-free DNA can be detected even if the tumor size is small because it detects very small amount of mutation gene in the blood. In addition, the detection of tumor cell DNA from circulating blood can be a clinical decision making point whether to continue or stop chemotherapy.
In this study, the investigators collect whole blood from patients with ovarian cancer undergoing surgery. Control samples will be obtained from patients undergoing surgery for benign adnexal disease with CA125 >35U/ml. In ovarian cancer patients, blood samples will be collected prospectively every 3 months after surgery. Mutations found at the initial sample will be monitored during chemotherapy to investigate the ctDNA pattern. The primary outcome will be progression free survival (PFS).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer group | – | –Patients pathologically diagnosed with ovarian cancer |
| Control group | – | –Patients with benign or borderline adnexal mass |
Who may qualify
- Ages
- 19 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, with epithelial ovarian cancer and patients with benign adnexal disease with serum CA-125 >35 U/mL
Key inclusion criteria (3 listed)
- Female, over 19 years of age;
- Patients with epithelial ovarian cancer
- Patients with Serum CA-125 >35 U/mL
Key exclusion criteria (5 listed)
- Patients in pregnancy
- Patients being treated for cancer of other organs, including gynecological cancer.
- Patients who has difficulty reading and understanding Korean.
- The tester's determination that the patient will not be able to comply with the clinical trial procedures.
- Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.
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 (PFS)
Time frame: 2 years
Determine Progression free survival (PFS) according to ctDNA pattern at time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- 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.
Jung-Yun LEE, M.D. principal investigator
Department of Obstetrics and Gynecology, Yonsei University College of Medicine
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 Yonsei University at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 26 Aug 2022. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (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 26 Aug 2022.