Ovarian CancerNCT05931055
The Effectiveness of Liquid Biopsy in Differential Diagnosis and Early Screening of Epithelial Ovarian Cancer
An observational study of Ovarian Cancer and Differentiating, run by Peking Union Medical College Hospital.
Trial summary
At present, there is a lack of effective screening methods. It is urgent to explore new non-invasive detection methods for early diagnosis of epithelial ovarian cancer and non-invasive differentiation methods for benign and malignant ovarian tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Differentiating, Diagnosis
- What is being tested?
- Fragmentomics
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2032
- 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
- Adult, Older adult
Study population: female aged over 18 years old, having mass in accessory area, receiving surgery
Who may be able to join
- Age ≥ 18 years old, female;
- Suspicious or considering mass in the accessory area, requiring surgical treatment and obtaining pathology of ovarian tissue;
- Having pelvic imaging evaluation results, including ultrasound, MRI, CT, or PET/CT;
- Serum CA125 and HE4 tests are tested before surgery, and ROMA evaluation results is obtained;
- Volunteer to participate in this research and sign an informed consent form; (6) Good compliance and regular follow-up.
Who cannot join
- Patients with confirmed ovarian cancer who have undergone surgery and obtained histopathology;
- Patients who have received chemotherapy or pelvic radiation therapy within 6 months prior to sample collection;
- Researchers have confirmed patients with recurrent ovarian cancer, or ovarian cancer patients who have received chemotherapy and/or surgical treatment;
- Contraindications for surgical evaluation and inability to obtain ovarian pathology or surgical pathological information;
- Samples that do not meet the requirements for collecting and storing assessment reagent samples; Or contaminated or suspected contaminated samples;
- Samples with missing, incomplete, and untraceable clinical information of corresponding patients;
- Pregnant and lactating women;
- Patients who cannot cooperate with examinations, have poor compliance, and cannot follow up regularly.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of Liquid Biopsy in Differential Diagnosis of Benign and Malignant Ovarian Tumors and Early Screening of Epithelial Ovarian Cancer, and the Exploration of Invasive Mechanisms of Epithelial Ovarian Cancer
At present, there is a lack of effective screening methods. It is urgent to explore new non-invasive detection methods for early diagnosis of epithelial ovarian cancer and non-invasive differentiation methods for benign and malignant ovarian tumors.
Liquid biopsy technology has great potential for early screening of tumors. The fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif.
Read more
The number of proteins in a proteome can sometimes exceed the number of genomes. It includes "structural Proteomics" and "functional Proteomics". At present, research has explored the use of urinary protein biomarkers for early diagnosis of gastric cancer. "Deep Visual Proteomics (DVP)" reveals the mechanism driving tumor evolution and new therapeutic targets for tumors.
Using the currently mature low depth WGS sequencing technology, this study aims to explore its clinical application in the differentiation and early screening of epithelial ovarian cancer, as well as monitoring the course of epithelial ovarian cancer, including the detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). This study also explores the role of urine proteomics in the differentiation of benign and malignant ovarian tumors, early screening and invasiveness of epithelial ovarian cancer, and monitoring the course of epithelial ovarian cancer.
Read the detailed description
At present, there is a lack of effective screening methods. Numerous studies and practices have shown that tumor screening and early diagnosis and treatment can effectively prolong the overall survival period of cancer patients and reduce the economic burden of the disease. The traditional early screening methods for tumors in clinical practice, including imaging screening, endoscopic screening, and tumor marker screening, generally have defects such as strong invasiveness, significant discomfort during the screening process, low accuracy (false negative, false positive), and poor compliance. Therefore, it is urgent to explore new non-invasive detection methods for early diagnosis of epithelial ovarian cancer and non-invasive differentiation methods for benign and malignant ovarian tumors.
Liquid biopsy technology, as a non-invasive new detection technology, has great potential for early screening of tumors. CfDNA is an important marker for liquid biopsy and has been widely used in non-invasive prenatal examinations and cancer liquid biopsy research. The fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif.
Proteome changes with different tissue and even environmental states. During transcription, a gene can be spliced in multiple mRNA forms, and a proteome is not a direct product of a genome. The number of proteins in a proteome can sometimes exceed the number of genomes. It includes "structural Proteomics" and "functional Proteomics". The former is mainly the study of protein expression models, including protein amino acid sequence, analysis and spatial structure analysis, type analysis and quantity determination; The latter mainly focuses on the study of protein functional patterns, including protein function and protein-protein interactions. At present, research has explored the use of urinary protein biomarkers for early diagnosis of gastric cancer. "Deep Visual Proteomics (DVP)" reveals the mechanism driving tumor evolution and new therapeutic targets for tumors.
There is ample evidence to support the diagnostic value of fragment omics research in tumors. Using the currently mature low depth WGS sequencing technology, this study aims to explore its clinical application in the differentiation and early screening of epithelial ovarian cancer, as well as monitoring the course of epithelial ovarian cancer, including the detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). In addition, there is currently no research on the use of urine proteomics in the differentiation and early screening of ovarian cancer. This study also explores the role of urine proteomics in the differentiation of benign and malignant ovarian tumors, early screening and invasiveness of epithelial ovarian cancer, and monitoring the course of epithelial ovarian cancer.
- Conditions
- Ovarian Cancer, Differentiating, Diagnosis
- Being tested
- Fragmentomics
- Medical subject headings
- Ovarian Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FragmentomicsDiagnostic test
The fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif. Fragomics relies on WGS (Whole Genome Sequencing), and the target covers the whole Genomics level. Thus, the cfDNA Fragmentomics testing can help differentiation and early diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| ovarian cancer group | patients confirmed with ovarian cancer Receives: Diagnostic Test: Fragmentomics | |
| ovarian cyst group | patients confirmed with benign ovarian csyt Receives: Diagnostic Test: Fragmentomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copy number variation
Exploring the characteristics of cfDNA copy number variation in patients with epithelial ovarian cancer
Measured: 3 years follow-up after enrollment or till the end of research
Nucleosome Footprint
Exploring the characteristics of cfDNA nucleosome Footprint in patients with epithelial ovarian cancer
Measured: 3 years follow-up after enrollment or till the end of research
Fragment length
Exploring the characteristics of cfDNA fragment length in patients with epithelial ovarian cancer
Measured: 3 years follow-up after enrollment or till the end of research
Motif
Exploring the characteristics of cfDNA motif in patients with epithelial ovarian cancer
Measured: 3 years follow-up after enrollment or till the end of research
Secondary outcomes (2)
Construction and validation a risk prediction model
constructing a risk prediction model based on fragmentomics characteristics and clinical data, for early screening and differential diagnosis of epithelial ovarian cancer, and for monitoring the course of epithelial ovarian cancer patients, including detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). The fragmentomics characteristics include copy number variation, nucleosome Footprint, fragment length and motif.
Measured: 3 years follow-up after enrollment or till the end of research
urinary proteomics
Exploring the characteristics of urinary proteomics in patients with epithelial ovarian cancer, combined with clinical and pathological data of patients, for early screening and differential diagnosis of epithelial ovarian cancer, and for monitoring the course of epithelial ovarian cancer patients, including detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). Further exploration of the invasive mechanism of epithelial ovarian cancer using urinary proteomics.
Measured: 3 years follow-up after enrollment or till the end of research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2032 (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 Peking Union Medical College HospitalThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Li, doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931055
- Sponsor's protocol ID
- K4059
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 5 Jul 2023
- 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Liquid Biopsy in Differential Diagnosis of Benign and Malignant Ovarian Tumors and Early Screening of Epithelial Ovarian Cancer, and the Exploration of Invasive Mechanisms of Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05931055
- Acronym / sponsor ID
- K4059
- Conditions
- Ovarian Cancer, Differentiating, Diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 5 Jul 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.
At present, there is a lack of effective screening methods. It is urgent to explore new non-invasive detection methods for early diagnosis of epithelial ovarian cancer and non-invasive differentiation methods for benign and malignant ovarian tumors.
Liquid biopsy technology has great potential for early screening of tumors. The fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif.
The number of proteins in a proteome can sometimes exceed the number of genomes. It includes "structural Proteomics" and "functional Proteomics". At present, research has explored the use of urinary protein biomarkers for early diagnosis of gastric cancer. "Deep Visual Proteomics (DVP)" reveals the mechanism driving tumor evolution and new therapeutic targets for tumors.
Using the currently mature low depth WGS sequencing technology, this study aims to explore its clinical application in the differentiation and early screening of epithelial ovarian cancer, as well as monitoring the course of epithelial ovarian cancer, including the detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). This study also explores the role of urine proteomics in the differentiation of benign and malignant ovarian tumors, early screening and invasiveness of epithelial ovarian cancer, and monitoring the course of epithelial ovarian cancer.
Detailed description
At present, there is a lack of effective screening methods. Numerous studies and practices have shown that tumor screening and early diagnosis and treatment can effectively prolong the overall survival period of cancer patients and reduce the economic burden of the disease. The traditional early screening methods for tumors in clinical practice, including imaging screening, endoscopic screening, and tumor marker screening, generally have defects such as strong invasiveness, significant discomfort during the screening process, low accuracy (false negative, false positive), and poor compliance. Therefore, it is urgent to explore new non-invasive detection methods for early diagnosis of epithelial ovarian cancer and non-invasive differentiation methods for benign and malignant ovarian tumors.
Liquid biopsy technology, as a non-invasive new detection technology, has great potential for early screening of tumors. CfDNA is an important marker for liquid biopsy and has been widely used in non-invasive prenatal examinations and cancer liquid biopsy research. The fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif.
Proteome changes with different tissue and even environmental states. During transcription, a gene can be spliced in multiple mRNA forms, and a proteome is not a direct product of a genome. The number of proteins in a proteome can sometimes exceed the number of genomes. It includes "structural Proteomics" and "functional Proteomics". The former is mainly the study of protein expression models, including protein amino acid sequence, analysis and spatial structure analysis, type analysis and quantity determination; The latter mainly focuses on the study of protein functional patterns, including protein function and protein-protein interactions. At present, research has explored the use of urinary protein biomarkers for early diagnosis of gastric cancer. "Deep Visual Proteomics (DVP)" reveals the mechanism driving tumor evolution and new therapeutic targets for tumors.
There is ample evidence to support the diagnostic value of fragment omics research in tumors. Using the currently mature low depth WGS sequencing technology, this study aims to explore its clinical application in the differentiation and early screening of epithelial ovarian cancer, as well as monitoring the course of epithelial ovarian cancer, including the detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). In addition, there is currently no research on the use of urine proteomics in the differentiation and early screening of ovarian cancer. This study also explores the role of urine proteomics in the differentiation of benign and malignant ovarian tumors, early screening and invasiveness of epithelial ovarian cancer, and monitoring the course of epithelial ovarian cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ovarian cancer group | – | Diagnostic Test: Fragmentomicspatients confirmed with ovarian cancer |
| ovarian cyst group | – | Diagnostic Test: Fragmentomicspatients confirmed with benign ovarian csyt |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- female aged over 18 years old, having mass in accessory area, receiving surgery
Key inclusion criteria (5 listed)
- Age ≥ 18 years old, female;
- Suspicious or considering mass in the accessory area, requiring surgical treatment and obtaining pathology of ovarian tissue;
- Having pelvic imaging evaluation results, including ultrasound, MRI, CT, or PET/CT;
- Serum CA125 and HE4 tests are tested before surgery, and ROMA evaluation results is obtained;
- Volunteer to participate in this research and sign an informed consent form; (6) Good compliance and regular follow-up.
Key exclusion criteria (8 listed)
- Patients with confirmed ovarian cancer who have undergone surgery and obtained histopathology;
- Patients who have received chemotherapy or pelvic radiation therapy within 6 months prior to sample collection;
- Researchers have confirmed patients with recurrent ovarian cancer, or ovarian cancer patients who have received chemotherapy and/or surgical treatment;
- Contraindications for surgical evaluation and inability to obtain ovarian pathology or surgical pathological information;
- Samples that do not meet the requirements for collecting and storing assessment reagent samples; Or contaminated or suspected contaminated samples;
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 |
|---|---|---|
| FragmentomicsThe fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif. Fragomics relies on WGS (Whole Genome Sequencing), and the target covers the whole Genomics level. Thus, the cfDNA Fragmentomics testing can help differentiation and early diagnosis. | Diagnostic test | ovarian cancer group, ovarian cyst group |
Primary outcome
Copy number variation
Time frame: 3 years follow-up after enrollment or till the end of research
Exploring the characteristics of cfDNA copy number variation in patients with epithelial ovarian cancer
Nucleosome Footprint
Time frame: 3 years follow-up after enrollment or till the end of research
Exploring the characteristics of cfDNA nucleosome Footprint in patients with epithelial ovarian cancer
Fragment length
Time frame: 3 years follow-up after enrollment or till the end of research
Exploring the characteristics of cfDNA fragment length in patients with epithelial ovarian cancer
Motif
Time frame: 3 years follow-up after enrollment or till the end of research
Exploring the characteristics of cfDNA motif in patients with epithelial ovarian cancer
2 secondary outcomes
Construction and validation a risk prediction model
Time frame: 3 years follow-up after enrollment or till the end of research
urinary proteomics
Time frame: 3 years follow-up after enrollment or till the end of research
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 5 Jul 2023.
- 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, doctor principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Differentiating, run by Peking Union Medical College Hospital.
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 5 inclusion and 8 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 5 Jul 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?
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, doctor (+86 13911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copy number variation (time frame: 3 years follow-up after enrollment or till the end of research). The study lists 4 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 5 Jul 2023.