High Grade Serous CarcinomaNCT03738319
Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
An observational study of High Grade Serous Carcinoma and Ovarian Cancer, run by Lei Li at 1 site in China.
Trial summary
This study aims to analyze the expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with high grade serous ovarian cancer (HGSOC) and benign gynecologic diseases. The candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Serous Carcinoma, Ovarian Cancer, Exosomes
- What is being tested?
- Sequencing of miRNA/lncRNA
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 23 Nov 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: There will be 20 patients of high grade serous ovarian cancer (HGSOC) and 20 patients with benign gynecologic diseases, whose data will be applied for construction of diagnostic model of miRNA/lncRNA from exosome. There will be 120 patients suspected of HGSOC, whose data will be applied for validation of such diagnosis model.
Who may be able to join
- Confirmed primary high grade serous ovarian cancer
- Willing to accepted debulking surgeries and adjuvant chemotherapy
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
This study aims to analyze the expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with high grade serous ovarian cancer (HGSOC) and benign gynecologic diseases. The candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.
- Being tested
- Sequencing of miRNA/lncRNA
- 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.
Sequencing of miRNA/lncRNAGenetic
Next generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA)
| Study group | Role | What they receive |
|---|---|---|
| HGSOC group | This group includes patients of high grade serous ovarian cancer (HGSOC). Receives: Genetic: Sequencing of miRNA/lncRNA | |
| Control group | This group includes patients of benign gynecologic diseases as control. Receives: Genetic: Sequencing of miRNA/lncRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of miRNA/lncRNA
Differential expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) will be compared between HGSOC group and control group, hence candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.
Measured: One year
Secondary outcomes (1)
Progression-free survival
The progression-free survival of HGSOC patients will be compared between differential expressed candidate miRNA/lncRNA after they have completed debulking surgeries and adjuvant chemotherapy.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Nov 2018
- Primary completion23 Nov 2019 (estimated)
- Study completion23 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Serous CarcinomaStudies 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
- 160 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
- NCT03738319
- Sponsor's protocol ID
- EOC-EXOSOME
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available to all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03738319
- Acronym / sponsor ID
- EOC-EXOSOME
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 23 Nov 2019 (estimated)
- Study completion
- 23 Nov 2019 (estimated)
- First posted
- 13 Nov 2018 (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 aims to analyze the expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with high grade serous ovarian cancer (HGSOC) and benign gynecologic diseases. The candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGSOC group | – | Genetic: Sequencing of miRNA/lncRNAThis group includes patients of high grade serous ovarian cancer (HGSOC). |
| Control group | – | Genetic: Sequencing of miRNA/lncRNAThis group includes patients of benign gynecologic diseases as control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There will be 20 patients of high grade serous ovarian cancer (HGSOC) and 20 patients with benign gynecologic diseases, whose data will be applied for construction of diagnostic model of miRNA/lncRNA from exosome. There will be 120 patients suspected of HGSOC, whose data will be applied for validation of such diagnosis model.
Key inclusion criteria (5 listed)
- Confirmed primary high grade serous ovarian cancer
- Willing to accepted debulking surgeries and adjuvant chemotherapy
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| Sequencing of miRNA/lncRNANext generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA) | Genetic | Control group, HGSOC group |
Primary outcome
Differential expression of miRNA/lncRNA
Time frame: One year
Differential expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) will be compared between HGSOC group and control group, hence candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.
1 secondary outcome
Progression-free survival
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Yes. All data will be available to all researchers.
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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. This study is not recruiting at the moment.
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 High Grade Serous Carcinoma and 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (13911988831 ext. 86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential expression of miRNA/lncRNA (time frame: One year). 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 14 Nov 2018.