Ovarian CancerNCT05175326
Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs
An observational study of Ovarian Cancer and Organoid, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. The purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ovarian Cancer, Organoid
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with histologically confirmed ovarian cancer from Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Who may be able to join
- Patients with ovarian cancer who are diagnosed as ovarian cancer by tissue and/or cytology and need neoadjuvant, adjuvant or standard treatment Age 18-75 years old (including 18 years old and 75 years old) It is clear that there are measurable lesions (according to RECIST1.1)
Who cannot join
- Patients with concurrent radiotherapy and chemotherapy, less than half a year of radiotherapy, or patients undergoing radiotherapy during the study period During the study period, patients need other tumor treatment methods such as surgery, intervention, radiofrequency ablation, etc.
- Immune deficiency or severe bone marrow suppression The patient has severe liver and kidney disease, cardiovascular disease, blood disease, etc.
- Illegal use of drugs or chronic alcohol abuse or total daily alcohol intake> 50 g/d Lack of autonomy, unable to walk, or unable to participate in the 6-month follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Rao Qunxian, +86 13902250700, raoqx3@mail.sysu.edu.cn
About this study
This is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. The purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the clinical efficacy of anti-cancer drugs
- Conditions
- Ovarian Cancer, Organoid
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of the response to treatment by the patient-derived organoids
The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.
Measured: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Nov 2022 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rao Qunxian, Study director, The Sun Yat-sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175326
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-294
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs
- ClinicalTrials.gov ID
- NCT05175326
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-294
- Conditions
- Ovarian Cancer, Organoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 3 Jan 2022 (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 is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. The purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the clinical efficacy of anti-cancer drugs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with histologically confirmed ovarian cancer from Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Key inclusion criteria (1 listed)
- Patients with ovarian cancer who are diagnosed as ovarian cancer by tissue and/or cytology and need neoadjuvant, adjuvant or standard treatment Age 18-75 years old (including 18 years old and 75 years old) It is clear that there are measurable lesions (according to RECIST1.1)
Key exclusion criteria (3 listed)
- Patients with concurrent radiotherapy and chemotherapy, less than half a year of radiotherapy, or patients undergoing radiotherapy during the study period During the study period, patients need other tumor treatment methods such as surgery, intervention, radiofrequency ablation, etc.
- Immune deficiency or severe bone marrow suppression The patient has severe liver and kidney disease, cardiovascular disease, blood disease, etc.
- Illegal use of drugs or chronic alcohol abuse or total daily alcohol intake> 50 g/d Lack of autonomy, unable to walk, or unable to participate in the 6-month follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of the response to treatment by the patient-derived organoids
Time frame: 2021-2022
The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Rao Qunxian study director
The Sun Yat-sen Memorial Hospital of Sun Yat-Sen 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 Ovarian Cancer and Organoid, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 1 inclusion and 3 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 3 Jan 2022. 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 Rao Qunxian (13902250700, raoqx3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of the response to treatment by the patient-derived organoids (time frame: 2021-2022). 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 3 Jan 2022.