Ovarian CancerNCT06558019
Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence
An observational study of Ovarian Cancer, run by Lei Li at 1 site in China.
Trial summary
Ovarian cancer is the third most common malignant tumor in China's female reproductive system in terms of incidence rate and the first in terms of mortality. Surgery and systemic chemotherapy are the cornerstone of first-line treatment for patients with epithelial 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
- How many people
- 509 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2026
- 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: The research subjects are patients with epithelial ovarian cancer.
Who may be able to join
- Women over 18 years old
- Pathological diagnosis of stage I-IV epithelial ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2
- Expected survival period exceeding 6 months
- Within 8 weeks between diagnosis and enrollment
- Sign informed consent form
Who cannot join
- Non epithelial ovarian tumors
- History of cancer in the past 5 years
- Received systematic treatment for ovarian cancer
- Gestation
- Previous bilateral oophorectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence: a Prospective Multicenter Observational Cohort
Ovarian cancer is the third most common malignant tumor in China's female reproductive system in terms of incidence rate and the first in terms of mortality. Surgery and systemic chemotherapy are the cornerstone of first-line treatment for patients with epithelial ovarian cancer. The efficacy rate of first-line platinum combined with taxus chemotherapy is more than 80%, and more than half of them reach complete remission (CR). However, even if advanced patients reach CR, 50% -70% still relapse, with a median disease-free interval of 16 months. Most patients lack typical symptoms when they relapse. The sensitivity of CA125 in monitoring recurrence is poor (43-74%), which means that more than 25% of ovarian cancer patients cannot detect recurrence in a timely manner during follow-up. Therefore, more sensitive biomarkers are needed for monitoring ovarian cancer recurrence after treatment. More and more studies have explored the application value of extracellular vesicle technology in the diagnosis and treatment of ovarian cancer, including auxiliary diagnosis, prognosis, monitoring, etc. China already has an approved exosome ovarian cancer diagnostic product by the National Medical Products Administration, namely the Ovarian Cancer Diagnostic Score (OCS) product based on exosome technology, which is also the world's first exosome technology diagnostic kit for ovarian cancer. Clinical trial data shows that OCS products have demonstrated excellent performance in distinguishing between benign and malignant ovarian tumors. Under high specificity (90.2%), it has a higher sensitivity than serum CA125, reaching 95.5% (95% CI 92.7% -97.3%), and has a sensitivity of 89.7% in the diagnosis of stage I ovarian cancer. OCS exhibits better sensitivity than CA125, especially in early ovarian cancer, suggesting that OCS may be a better tool for monitoring recurrence in ovarian cancer patients.The main purpose of this study is to establish an OCS scoring ovarian cancer recurrence prediction and monitoring model based on exosome technology, providing an effective tool for clinical ovarian cancer recurrence prediction and monitoring. Secondly, we hope to explore the correlation between OCS score and tumor staging, chemotherapy sensitivity, PFS, OS indicators, etc., and determine the performance of recurrence prediction models in different subgroups, such as different pathological subtypes of ovarian cancer and different treatment methods.
Read the detailed description
This research subjects are patients with epithelial ovarian cancer.The training set adopts case-control analysis, using the PASS software Test for Two Related Proportions in a Matched Case Control Design module. Setting α=0.05, β=0.1, assuming P0=10%, OR=4, and a 1:1 ratio between the case group and the control group, 101 cases need to be separately enrolled in the case group and the control group. The case group consists of patients who have achieved response to first-line treatment and experienced imaging recurrence. Therefore, 101 recurrence events need to be observed during the 18 month follow-up period. Assuming that the response rate to platinum based chemotherapy in first-line treatment is 80% and the recurrence rate at 18 months is 50%, they need to be enrolled in group 101 / 80% / 50%=253 cases. The control group consisted of at least 101 patients who achieved CR with first-line treatment and had no recurrence of OCS imaging during follow-up testing. Assuming a CR rate of 70% with first-line treatment, 145 patients need to be enrolled. Therefore, the inclusion of 253 cases can meet the sample size requirements for both the case group and the control group. Considering a dropout rate of 15%, a total of 298 cases need to be enrolled. Evaluate the performance of the validation set in predicting recurrence. Assuming the sensitivity of predicting recurrence increases from 75% to 90%, with α=0.05 and β=0.2, 45 recurrence events are required. Assuming an 80% response rate to platinum based chemotherapy as first-line treatment and a 50% recurrence rate within 18 months, 45 recurrence events observed during the 18 month follow-up period need to be enrolled / 80% / 50%=113 patients. Assuming a specificity of not less than 90%, α=0.05, β=0.2, 179 patients are required for enrollment. Assuming a dropout rate of 15%, a total of 211 patients need to be included. Taking into account both sensitivity and specificity performance evaluation, a total of 211 patients were included in the validation set.
This project will announce the findings and main achievements of this research through the publication of core Chinese papers and SCI indexed articles. In addition, this project will organize experts in the field to explore consensus and write guidelines, announcing the technical routes and application directions related to this research.
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Exosome, Extracellular vesicles, Cancer recurrence, Liquid biopsy, CA-125
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Progression-free survival after diagnosis
Measured: 2 yeas
overall survival
Overall survival after diagnosis
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 posted16 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- Retrospective
- Enrolment
- 509 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558019
- Sponsor's protocol ID
- OCS-OvaRPM
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence: a Prospective Multicenter Observational Cohort
- ClinicalTrials.gov ID
- NCT06558019
- Acronym / sponsor ID
- OCS-OvaRPM
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Exosome, Extracellular vesicles, Cancer recurrence, Liquid biopsy, CA-125
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 509 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Aug 2024 (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 third most common malignant tumor in China's female reproductive system in terms of incidence rate and the first in terms of mortality. Surgery and systemic chemotherapy are the cornerstone of first-line treatment for patients with epithelial ovarian cancer. The efficacy rate of first-line platinum combined with taxus chemotherapy is more than 80%, and more than half of them reach complete remission (CR). However, even if advanced patients reach CR, 50% -70% still relapse, with a median disease-free interval of 16 months. Most patients lack typical symptoms when they relapse. The sensitivity of CA125 in monitoring recurrence is poor (43-74%), which means that more than 25% of ovarian cancer patients cannot detect recurrence in a timely manner during follow-up. Therefore, more sensitive biomarkers are needed for monitoring ovarian cancer recurrence after treatment. More and more studies have explored the application value of extracellular vesicle technology in the diagnosis and treatment of ovarian cancer, including auxiliary diagnosis, prognosis, monitoring, etc. China already has an approved exosome ovarian cancer diagnostic product by the National Medical Products Administration, namely the Ovarian Cancer Diagnostic Score (OCS) product based on exosome technology, which is also the world's first exosome technology diagnostic kit for ovarian cancer. Clinical trial data shows that OCS products have demonstrated excellent performance in distinguishing between benign and malignant ovarian tumors. Under high specificity (90.2%), it has a higher sensitivity than serum CA125, reaching 95.5% (95% CI 92.7% -97.3%), and has a sensitivity of 89.7% in the diagnosis of stage I ovarian cancer. OCS exhibits better sensitivity than CA125, especially in early ovarian cancer, suggesting that OCS may be a better tool for monitoring recurrence in ovarian cancer patients.The main purpose of this study is to establish an OCS scoring ovarian cancer recurrence prediction and monitoring model based on exosome technology, providing an effective tool for clinical ovarian cancer recurrence prediction and monitoring. Secondly, we hope to explore the correlation between OCS score and tumor staging, chemotherapy sensitivity, PFS, OS indicators, etc., and determine the performance of recurrence prediction models in different subgroups, such as different pathological subtypes of ovarian cancer and different treatment methods.
Detailed description
This research subjects are patients with epithelial ovarian cancer.The training set adopts case-control analysis, using the PASS software Test for Two Related Proportions in a Matched Case Control Design module. Setting α=0.05, β=0.1, assuming P0=10%, OR=4, and a 1:1 ratio between the case group and the control group, 101 cases need to be separately enrolled in the case group and the control group. The case group consists of patients who have achieved response to first-line treatment and experienced imaging recurrence. Therefore, 101 recurrence events need to be observed during the 18 month follow-up period. Assuming that the response rate to platinum based chemotherapy in first-line treatment is 80% and the recurrence rate at 18 months is 50%, they need to be enrolled in group 101 / 80% / 50%=253 cases. The control group consisted of at least 101 patients who achieved CR with first-line treatment and had no recurrence of OCS imaging during follow-up testing. Assuming a CR rate of 70% with first-line treatment, 145 patients need to be enrolled. Therefore, the inclusion of 253 cases can meet the sample size requirements for both the case group and the control group. Considering a dropout rate of 15%, a total of 298 cases need to be enrolled. Evaluate the performance of the validation set in predicting recurrence. Assuming the sensitivity of predicting recurrence increases from 75% to 90%, with α=0.05 and β=0.2, 45 recurrence events are required. Assuming an 80% response rate to platinum based chemotherapy as first-line treatment and a 50% recurrence rate within 18 months, 45 recurrence events observed during the 18 month follow-up period need to be enrolled / 80% / 50%=113 patients. Assuming a specificity of not less than 90%, α=0.05, β=0.2, 179 patients are required for enrollment. Assuming a dropout rate of 15%, a total of 211 patients need to be included. Taking into account both sensitivity and specificity performance evaluation, a total of 211 patients were included in the validation set.
This project will announce the findings and main achievements of this research through the publication of core Chinese papers and SCI indexed articles. In addition, this project will organize experts in the field to explore consensus and write guidelines, announcing the technical routes and application directions related to this research.
Study design
- Observational model
- Cohort
- 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
- The research subjects are patients with epithelial ovarian cancer.
Key inclusion criteria (6 listed)
- Women over 18 years old
- Pathological diagnosis of stage I-IV epithelial ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2
- Expected survival period exceeding 6 months
- Within 8 weeks between diagnosis and enrollment
Key exclusion criteria (5 listed)
- Non epithelial ovarian tumors
- History of cancer in the past 5 years
- Received systematic treatment for ovarian cancer
- Gestation
- Previous bilateral oophorectomy
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: 2 yeas
Progression-free survival after diagnosis
overall survival
Time frame: 2 years
Overall survival after diagnosis
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 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
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 Lei 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 6 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: opening soon, as of the sponsor's last update on 16 Aug 2024. 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?
Contact Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2 yeas). The study lists 2 primary outcomes in all. 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 16 Aug 2024.