Epithelial Ovarian CancerctDNA_EOCNCT03155451
Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.
An observational study of Epithelial Ovarian Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- methylation markers screening
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2017to 18 Oct 2017
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive colletion of patinets with ovarian cancer treatment at our clinical centre
Who may be able to join
- people aged 18years to 80years;
- Diagnosis of ovarian cancer is confirmed by two Pathologists independently;
- Pregnancy tests are negative.
Who cannot join
- With other type of malignancies;
- someone who refuse to participate the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200126
About this study
Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.
Read the detailed description
Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.
ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.
This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- methylation markers screening
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylation markers screeningDiagnostic test
ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis
| Study group | Role | What they receive |
|---|---|---|
| Epithelial ovarian cancer | patients receive the ctDNA methylation markers screening Receives: Diagnostic Test: methylation markers screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological diagnosis of ovarian lumps
Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information.
Measured: One week after surgery
Secondary outcomes (2)
sensitivity (true positive rate)
The proportion of persons with disease who have a positive test (positive test results among persons with disease)
Measured: 2 year
Specificity (true negative rate)
The proportion of persons without disease who have a negative test (negative test results among persons without disease)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start14 Aug 2017
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Yu, RenJi Hospital
- Investigators
- Yu Wang, M.D., Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155451
- Sponsor's protocol ID
- [2017]012
- Acronym
- ctDNA_EOC
- Status last verified
- Oct 2017
- First submitted
- 13 May 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wen L, Li J, Guo H, Liu X, Zheng S, Zhang D, Zhu W, Qu J, Guo L, Du D, Jin X, Zhang Y, Gao Y, Shen J, Ge H, Tang F, Huang Y, Peng J. Genome-scale detection of hypermethylated CpG islands in circulating cell-free DNA of hepatocellular carcinoma patients. Cell Res. 2015 Nov;25(11):1250-64. doi: 10.1038/cr.2015.126. Epub 2015 Oct 30.
PubMed 26516143Nick AM, Coleman RL, Ramirez PT, Sood AK. A framework for a personalized surgical approach to ovarian cancer. Nat Rev Clin Oncol. 2015 Apr;12(4):239-45. doi: 10.1038/nrclinonc.2015.26. Epub 2015 Feb 24.
PubMed 25707631
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT03155451
- Acronym / sponsor ID
- ctDNA_EOC / [2017]012
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 16 May 2017 (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.
Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.
Detailed description
Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.
ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.
This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epithelial ovarian cancer | – | Diagnostic Test: methylation markers screeningpatients receive the ctDNA methylation markers screening |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive colletion of patinets with ovarian cancer treatment at our clinical centre
Key inclusion criteria (3 listed)
- people aged 18years to 80years;
- Diagnosis of ovarian cancer is confirmed by two Pathologists independently;
- Pregnancy tests are negative.
Key exclusion criteria (2 listed)
- With other type of malignancies;
- someone who refuse to participate the study.
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 |
|---|---|---|
| methylation markers screeningctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis | Diagnostic test | Epithelial ovarian cancer |
Primary outcome
Pathological diagnosis of ovarian lumps
Time frame: One week after surgery
Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information.
2 secondary outcomes
sensitivity (true positive rate)
Time frame: 2 year
Specificity (true negative rate)
Time frame: 2 year
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 19 Oct 2017.
- Background: PubMed 26516143Wen L, Li J, Guo H, Liu X, Zheng S, Zhang D, Zhu W, Qu J, Guo L, Du D, Jin X, Zhang Y, Gao Y, Shen J, Ge H, Tang F, Huang Y, Peng J. Genome-scale detection of hypermethylated CpG islands in circulating cell-free DNA of hepatocellular carcinoma patients. Cell Res. 2015 Nov;25(11):1250-64. doi: 10.1038/cr.2015.126. Epub 2015 Oct 30.
- Background: PubMed 25707631Nick AM, Coleman RL, Ramirez PT, Sood AK. A framework for a personalized surgical approach to ovarian cancer. Nat Rev Clin Oncol. 2015 Apr;12(4):239-45. doi: 10.1038/nrclinonc.2015.26. Epub 2015 Feb 24.
- Individual participant dataSharing planned: Undecided
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Epithelial Ovarian Cancer
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.
Yu Wang, M.D. principal investigator
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
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 Epithelial Ovarian Cancer, run by RenJi 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 3 inclusion and 2 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 19 Oct 2017. 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?
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?
Pathological diagnosis of ovarian lumps (time frame: One week after surgery). 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 NCT03155451, which also lists 2 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 19 Oct 2017.