Ovarian CancerNCT06249308
Liquid Biopsy-based Early Detection of Ovarian Cancer: a Proof-of-concept Study ( PROFOUND-OC )
An observational study of Ovarian Cancer, run by Fudan University at 3 sites in China.
Trial summary
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from newly diagnosed ovarian cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Blood collection
- How many people
- 168 participants
- Where
- 3 sitesChina
- Study dates
- 18 Dec 2023to 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed ovarian cancer or individuals with a high suspicion for OC will be invited to participate in this proof-of-concept study
Who may be able to join
- 40-75 years old
- Clinically and/or pathologically diagnosed ovarian cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Who cannot join
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
- Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- Other conditions that the investigators considered are not suitable for the enrollment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 110042
Huaiwu Lu, M.D., Ph.D., +8618688395806, luhuaiwu@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hao Wen, M.D., Ph.D., +8618017317873, wenhao_fdc@163.com
- Not yet recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Zhuo Yang, M.D., Ph.D., +8618940258361, yangzhuo@cancerhosp-ln-cmu.com
About this study
Official title: A Multi-center, Perspective, Observational Case-control Study to Develop and Validate an Ovarian Cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from newly diagnosed ovarian cancer.
Read the detailed description
Peripheral blood samples from ovarian cancer (OC) patients will be prospectively collected to identify cancer-specific circulating signals by analyzing cell free DNA. Based on the comprehensive molecular profiling, a machine learning-driven noninvasive test will be trained and validated through a two-stage approach in clinically annotated individuals. Approximately 168 stage I-II OC patients will be enrolled in this study. Age-matched female controls included in model development were recruited in another study, which are volunteers without a cancer diagnosis after routine medical screening.
- Conditions
- Ovarian Cancer
- Being tested
- Blood collection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood sample will be collected
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer | Participants with new diagnosis of ovarian cancer, from whom a peripheral blood sample will be collected. Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of cfDNA methylation-based model for discriminating ovarian cancer versus non-cancer.
Sensitivities of cfDNA methylation-based model in detecting OC at specificity of 99% and 95%, respectively.
Measured: 12 months
Secondary outcomes (2)
The performance of model using multi-omics data for discriminating ovarian cancer versus non-cancer
Sensitivities of multi-omics model which combines methylation signature and fragmentomic features in detecting OC at specificity of 99% and 95%, respectively.
Measured: 12 months
The performance of pre-defined model in clinical sub-groups of interest
Sensitivity of pre-defined model in different pathological subtypes or different age groups or tumor marker-negative cases.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start18 Dec 2023
- Primary completion31 Dec 2025 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Responsible party
- Principal investigator, Hao Wen, Fudan University
- Investigators
- Hao Wen, M.D., Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249308
- Sponsor's protocol ID
- PROFOUND -OC
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Perspective, Observational Case-control Study to Develop and Validate an Ovarian Cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning
- ClinicalTrials.gov ID
- NCT06249308
- Acronym / sponsor ID
- PROFOUND -OC
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Feb 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.
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from newly diagnosed ovarian cancer.
Detailed description
Peripheral blood samples from ovarian cancer (OC) patients will be prospectively collected to identify cancer-specific circulating signals by analyzing cell free DNA. Based on the comprehensive molecular profiling, a machine learning-driven noninvasive test will be trained and validated through a two-stage approach in clinically annotated individuals. Approximately 168 stage I-II OC patients will be enrolled in this study. Age-matched female controls included in model development were recruited in another study, which are volunteers without a cancer diagnosis after routine medical screening.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer | – | Other: Blood collectionParticipants with new diagnosis of ovarian cancer, from whom a peripheral blood sample will be collected. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed ovarian cancer or individuals with a high suspicion for OC will be invited to participate in this proof-of-concept study
Key inclusion criteria (4 listed)
- 40-75 years old
- Clinically and/or pathologically diagnosed ovarian cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Key exclusion criteria (7 listed)
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
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 |
|---|---|---|
| Blood collectionBlood sample will be collected | Other | Ovarian cancer |
Primary outcome
The performance of cfDNA methylation-based model for discriminating ovarian cancer versus non-cancer.
Time frame: 12 months
Sensitivities of cfDNA methylation-based model in detecting OC at specificity of 99% and 95%, respectively.
2 secondary outcomes
The performance of model using multi-omics data for discriminating ovarian cancer versus non-cancer
Time frame: 12 months
The performance of pre-defined model in clinical sub-groups of interest
Time frame: 12 months
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 8 Feb 2024.
- 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.
Hao Wen, M.D., Ph.D. principal investigator
Fudan University
3 sites 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 Fudan University at 3 sites 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 7 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Hao Wen, M.D., Ph.D. (+8618017317873, wenhao_fdc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of cfDNA methylation-based model for discriminating ovarian cancer versus non-cancer. (time frame: 12 months). 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 8 Feb 2024.