Ovarian High Grade Serous CarcinomaNCT03794115
Immune Repertoire of Ovarian HGSC
An observational study of Ovarian High Grade Serous Carcinoma and Immune Repertoire, run by Lei Li at 1 site in China.
Trial summary
In this preliminary study, peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma at several points: before any treatment, after the debulking surgery, and after all the proposed chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian High Grade Serous Carcinoma, Immune Repertoire, T Lymphocyte Receptor
- What is being tested?
- Treatment for ovarian cancer
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2019to 1 Jan 2022
- 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: Patients confirmed of primary ovarian high grade serous carcinoma, aged 18 years or older and accept systematic treatment including debulking surgery and platinum-based chemotherapy.
Who may be able to join
- Confirmed of primary ovarian high grade serous carcinoma
- Aged 18 years or older
- No immunosuppressive disease
- 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
Official title: Differential Expression of Immune Repertoire of T/B Lymphocytes in Ovarian High Grade Serous Carcinoma
In this preliminary study, peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma at several points: before any treatment, after the debulking surgery, and after all the proposed chemotherapy. The differential expression of the T/B lymphocyte receptors in these samples will be analyzed with the platinum-based treatment and survival outcomes of the patients. The primary objective is the expression rates of T/B lymphocyte receptors in different stages of checking points.
- Conditions
- Ovarian High Grade Serous Carcinoma, Immune Repertoire, T Lymphocyte Receptor, B Lymphocyte Receptor
- Being tested
- Treatment for ovarian cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for ovarian cancerProcedure or surgery
The treatment for ovarian cancer includes the debulking surgery and platinum-based chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression rates of T lymphocyte receptors
Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy
Measured: One year
Expression rates of B lymphocyte receptors
Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start3 Jan 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794115
- Sponsor's protocol ID
- EOC-IMMUNE
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Expression of Immune Repertoire of T/B Lymphocytes in Ovarian High Grade Serous Carcinoma
- ClinicalTrials.gov ID
- NCT03794115
- Acronym / sponsor ID
- EOC-IMMUNE
- Conditions
- Ovarian High Grade Serous Carcinoma, Immune Repertoire, T Lymphocyte Receptor, B Lymphocyte Receptor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 4 Jan 2019 (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.
In this preliminary study, peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma at several points: before any treatment, after the debulking surgery, and after all the proposed chemotherapy. The differential expression of the T/B lymphocyte receptors in these samples will be analyzed with the platinum-based treatment and survival outcomes of the patients. The primary objective is the expression rates of T/B lymphocyte receptors in different stages of checking points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients confirmed of primary ovarian high grade serous carcinoma, aged 18 years or older and accept systematic treatment including debulking surgery and platinum-based chemotherapy.
Key inclusion criteria (4 listed)
- Confirmed of primary ovarian high grade serous carcinoma
- Aged 18 years or older
- No immunosuppressive disease
- 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 |
|---|---|---|
| Treatment for ovarian cancerThe treatment for ovarian cancer includes the debulking surgery and platinum-based chemotherapy. | Procedure or surgery | – |
Primary outcome
Expression rates of T lymphocyte receptors
Time frame: One year
Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy
Expression rates of B lymphocyte receptors
Time frame: One year
Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- 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. This study is not recruiting at the moment.
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 High Grade Serous Carcinoma and Immune Repertoire, 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 4 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 4 Jan 2019. 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. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression rates of T lymphocyte receptors (time frame: One year). 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?
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 4 Jan 2019.