Ovarian NeoplasmsNCT07593833
Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
An observational study of Ovarian Neoplasms and Ovarian Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms, Ovarian Cancer, Early Detection of Cancer
- What is being tested?
- Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Dec 2029
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with complex ovarian or adnexal masses, including suspected ovarian-origin pelvic masses, who are planned to undergo first-time surgery or biopsy/pathologic sampling related to the current lesion at participating centers and are expected to have a postoperative pathologic diagnosis available as the reference standard. The main analysis population consists of participants with pathologically confirmed early-stage invasive ovarian malignancies (FIGO 2014 stage IA-IIB) and participants with pathologically confirmed benign ovarian or adnexal diseases. Participants with borderline ovarian tumors, advanced-stage invasive malignancies, and, where available, high-risk or precursor lesions may also be enrolled as exploratory cohorts.
Who may be able to join
- Female participants.
- Participants with an ovarian/adnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy/pathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.
- Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian/adnexal mass requiring differential diagnosis.
- An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian/adnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.
- Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.
- The participant or her legally authorized representative voluntarily signs written informed consent after being fully informed.
Who cannot join
- The participant has already received systemic anti-tumor treatment for the current ovarian/adnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.
- No pathologic diagnosis is ultimately obtained for the current ovarian/adnexal mass, or no analyzable pathologic conclusion can be established.
- Imaging findings at screening are highly typical of benign mature cystic teratoma.
- Ovarian cancer combined with another malignant tumor.
- There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qinglei Gao, Dr., +86-27-83662681, qingleigao@hotmail.com
About this study
Official title: Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer
The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:
How well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?
Read more
Researchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.
Participants will:
Provide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Early Detection of Cancer
- Being tested
- Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
- Keywords
- Ovarian Cancer, Ovarian Neoplasms, cfDNA Methylation, Cell-Free DNA, DNA Methylation, Liquid Biopsy, Blood-Based Assay, Early Detection, Biomarker, Early Diagnosis, Diagnostic Performance, Ovarian Tumor
- 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.
Blood-Based cfDNA Methylation Assay for Ovarian Cancer DetectionDiagnostic test
Also called Plasma cfDNA Methylation Test
A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection. The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer | Women with ovarian cancer who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis. This cohort will be used to evaluate the sensitivity of the assay, including its performance in different histologic subtypes and early-stage disease. Receives: Diagnostic Test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection | |
| Benign Gynecologic Diseases | Women with benign gynecologic diseases who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis. This cohort will be used to evaluate the specificity of the assay. Receives: Diagnostic Test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity
Diagnostic sensitivity of the blood-based cfDNA methylation panel, defined as the proportion of participants with ovarian cancer who test positive, using final clinical and/or pathological diagnosis as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic specificity
Diagnostic specificity of the blood-based cfDNA methylation panel, defined as the proportion of participants without ovarian cancer who test negative, using final clinical and/or pathological diagnosis as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Secondary outcomes (5)
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for detecting early-stage ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for early-stage ovarian cancer detection
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for detecting early-stage ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in borderline ovarian tumors
Detection performance of the blood-based cfDNA methylation panel in participants with borderline ovarian tumors, using final clinical and/or pathological diagnosis as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in precursor lesions or high-risk populations
Detection performance of the blood-based cfDNA methylation panel in participants with precursor lesions or in populations at high risk for ovarian cancer, using final clinical and/or pathological diagnosis or clinical classification as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
Measured: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, The Affiliated Hospital of Qingdao University, Shanghai First Maternity and Infant Hospital, The First Affiliated Hospital of Soochow University, Xiangyang Central Hospital, The First Hospital of Jilin University, Renmin Hospital of Wuhan University, General Hospital of Ningxia Medical University, Wuhan Central Hospital, LanZhou University, Dongfang Hospital Affiliated to Tongji University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593833
- Sponsor's protocol ID
- TJ-OVMethy
- Status last verified
- Apr 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data are planned to be shared at this time.
Publications
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751Lofton-Day C, Model F, Devos T, Tetzner R, Distler J, Schuster M, Song X, Lesche R, Liebenberg V, Ebert M, Molnar B, Grutzmann R, Pilarsky C, Sledziewski A. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008 Feb;54(2):414-23. doi: 10.1373/clinchem.2007.095992. Epub 2007 Dec 18.
PubMed 18089654Nie Y, Gao X, Cai X, Wu Z, Liang Q, Xu G, Liu N, Gao P, Deng J, Xu H, Shen Z, Cao C, Chen F, Zhang N, Song Y, Sun M, Liu C, Zhou G, Han W, Dou J, Xie H, Yao L, Liu Z, Ji G, Wang X, Zhao Q, Shang L, Fan D, Han X, Ren J, Liang H, Wang Z, Wang J, Wu Q, Yu J, Wu K; MAGIS Study Group. Combining methylated SEPTIN9 and RNF180 plasma markers for diagnosis and early detection of gastric cancer. Cancer Commun (Lond). 2023 Nov;43(11):1275-1279. doi: 10.1002/cac2.12478. Epub 2023 Aug 16. No abstract available.
PubMed 37584087Liang W, Chen Z, Li C, Liu J, Tao J, Liu X, Zhao D, Yin W, Chen H, Cheng C, Yu F, Zhang C, Liu L, Tian H, Cai K, Liu X, Wang Z, Xu N, Dong Q, Chen L, Yang Y, Zhi X, Li H, Tu X, Cai X, Jiang Z, Ji H, Mo L, Wang J, Fan JB, He J. Accurate diagnosis of pulmonary nodules using a noninvasive DNA methylation test. J Clin Invest. 2021 May 17;131(10):e145973. doi: 10.1172/JCI145973.
PubMed 33793424Xu RH, Wei W, Krawczyk M, Wang W, Luo H, Flagg K, Yi S, Shi W, Quan Q, Li K, Zheng L, Zhang H, Caughey BA, Zhao Q, Hou J, Zhang R, Xu Y, Cai H, Li G, Hou R, Zhong Z, Lin D, Fu X, Zhu J, Duan Y, Yu M, Ying B, Zhang W, Wang J, Zhang E, Zhang C, Li O, Guo R, Carter H, Zhu JK, Hao X, Zhang K. Circulating tumour DNA methylation markers for diagnosis and prognosis of hepatocellular carcinoma. Nat Mater. 2017 Nov;16(11):1155-1161. doi: 10.1038/nmat4997. Epub 2017 Oct 9.
PubMed 29035356Zhang Q, Hu G, Yang Q, Dong R, Xie X, Ma D, Shen K, Kong B. A multiplex methylation-specific PCR assay for the detection of early-stage ovarian cancer using cell-free serum DNA. Gynecol Oncol. 2013 Jul;130(1):132-9. doi: 10.1016/j.ygyno.2013.04.048. Epub 2013 Apr 25.
PubMed 23623832
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07593833
- Acronym / sponsor ID
- TJ-OVMethy
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Early Detection of Cancer
- Keywords
- Ovarian Cancer, Ovarian Neoplasms, cfDNA Methylation, Cell-Free DNA, DNA Methylation, Liquid Biopsy, Blood-Based Assay, Early Detection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, The Affiliated Hospital of Qingdao University, Shanghai First Maternity and Infant Hospital, The First Affiliated Hospital of Soochow University, Xiangyang Central Hospital, The First Hospital of Jilin University, Renmin Hospital of Wuhan University, General Hospital of Ningxia Medical University, Wuhan Central Hospital, LanZhou University, Dongfang Hospital Affiliated to Tongji University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 18 May 2026 (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.
The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:
How well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?
Researchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.
Participants will:
Provide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer | – | Diagnostic Test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer DetectionWomen with ovarian cancer who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis. This cohort will be used to evaluate the sensitivity of the assay, including its performance in different histologic subtypes and early-stage disease. |
| Benign Gynecologic Diseases | – | Diagnostic Test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer DetectionWomen with benign gynecologic diseases who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis. This cohort will be used to evaluate the specificity of the assay. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with complex ovarian or adnexal masses, including suspected ovarian-origin pelvic masses, who are planned to undergo first-time surgery or biopsy/pathologic sampling related to the current lesion at participating centers and are expected to have a postoperative pathologic diagnosis available as the reference standard. The main analysis population consists of participants with pathologically confirmed early-stage invasive ovarian malignancies (FIGO 2014 stage IA-IIB) and participants with pathologically confirmed benign ovarian or adnexal diseases. Participants with borderline ovarian tumors, advanced-stage invasive malignancies, and, where available, high-risk or precursor lesions may also be enrolled as exploratory cohorts.
Key inclusion criteria (6 listed)
- Female participants.
- Participants with an ovarian/adnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy/pathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.
- Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian/adnexal mass requiring differential diagnosis.
- An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian/adnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.
- Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.
Key exclusion criteria (6 listed)
- The participant has already received systemic anti-tumor treatment for the current ovarian/adnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.
- No pathologic diagnosis is ultimately obtained for the current ovarian/adnexal mass, or no analyzable pathologic conclusion can be established.
- Imaging findings at screening are highly typical of benign mature cystic teratoma.
- Ovarian cancer combined with another malignant tumor.
- There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.
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-Based cfDNA Methylation Assay for Ovarian Cancer DetectionAlso: Plasma cfDNA Methylation TestA blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection. The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance. | Diagnostic test | Benign Gynecologic Diseases, Ovarian Cancer |
Primary outcome
Diagnostic sensitivity
Time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic sensitivity of the blood-based cfDNA methylation panel, defined as the proportion of participants with ovarian cancer who test positive, using final clinical and/or pathological diagnosis as the reference standard.
Diagnostic specificity
Time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic specificity of the blood-based cfDNA methylation panel, defined as the proportion of participants without ovarian cancer who test negative, using final clinical and/or pathological diagnosis as the reference standard.
5 secondary outcomes
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection
Time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for early-stage ovarian cancer detection
Time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in borderline ovarian tumors
Time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in precursor lesions or high-risk populations
Time frame: From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer
Time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 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 18 May 2026.
- Results publication: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Results publication: PubMed 18089654Lofton-Day C, Model F, Devos T, Tetzner R, Distler J, Schuster M, Song X, Lesche R, Liebenberg V, Ebert M, Molnar B, Grutzmann R, Pilarsky C, Sledziewski A. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008 Feb;54(2):414-23. doi: 10.1373/clinchem.2007.095992. Epub 2007 Dec 18.
- Results publication: PubMed 37584087Nie Y, Gao X, Cai X, Wu Z, Liang Q, Xu G, Liu N, Gao P, Deng J, Xu H, Shen Z, Cao C, Chen F, Zhang N, Song Y, Sun M, Liu C, Zhou G, Han W, Dou J, Xie H, Yao L, Liu Z, Ji G, Wang X, Zhao Q, Shang L, Fan D, Han X, Ren J, Liang H, Wang Z, Wang J, Wu Q, Yu J, Wu K; MAGIS Study Group. Combining methylated SEPTIN9 and RNF180 plasma markers for diagnosis and early detection of gastric cancer. Cancer Commun (Lond). 2023 Nov;43(11):1275-1279. doi: 10.1002/cac2.12478. Epub 2023 Aug 16. No abstract available.
- Results publication: PubMed 33793424Liang W, Chen Z, Li C, Liu J, Tao J, Liu X, Zhao D, Yin W, Chen H, Cheng C, Yu F, Zhang C, Liu L, Tian H, Cai K, Liu X, Wang Z, Xu N, Dong Q, Chen L, Yang Y, Zhi X, Li H, Tu X, Cai X, Jiang Z, Ji H, Mo L, Wang J, Fan JB, He J. Accurate diagnosis of pulmonary nodules using a noninvasive DNA methylation test. J Clin Invest. 2021 May 17;131(10):e145973. doi: 10.1172/JCI145973.
- Results publication: PubMed 29035356Xu RH, Wei W, Krawczyk M, Wang W, Luo H, Flagg K, Yi S, Shi W, Quan Q, Li K, Zheng L, Zhang H, Caughey BA, Zhao Q, Hou J, Zhang R, Xu Y, Cai H, Li G, Hou R, Zhong Z, Lin D, Fu X, Zhu J, Duan Y, Yu M, Ying B, Zhang W, Wang J, Zhang E, Zhang C, Li O, Guo R, Carter H, Zhu JK, Hao X, Zhang K. Circulating tumour DNA methylation markers for diagnosis and prognosis of hepatocellular carcinoma. Nat Mater. 2017 Nov;16(11):1155-1161. doi: 10.1038/nmat4997. Epub 2017 Oct 9.
- Results publication: PubMed 23623832Zhang Q, Hu G, Yang Q, Dong R, Xie X, Ma D, Shen K, Kong B. A multiplex methylation-specific PCR assay for the detection of early-stage ovarian cancer using cell-free serum DNA. Gynecol Oncol. 2013 Jul;130(1):132-9. doi: 10.1016/j.ygyno.2013.04.048. Epub 2013 Apr 25.
- Individual participant dataSharing planned: No. No individual participant data are planned to be shared at this time.
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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.
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 Neoplasms and Ovarian Cancer, run by Tongji Hospital 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 6 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 18 May 2026. 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 Qinglei Gao, Dr. (+86-27-83662681, qingleigao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity (time frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months). 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?
On the ClinicalTrials.gov record for NCT07593833, which also lists 6 linked publications.
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 18 May 2026.