Ovarian CancerNCT04768270
The Culture of Ovarian Cancer Organoids and Drug Screening
An observational study of Ovarian Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
The tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC)… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2022to 31 Dec 2024
- How long will I take part?
- 5 Years
- 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 70 years
- Women only
- Adult, Older adult
Study population: ovarian cancer patients who accept primary cytoreductive surgery
Who may be able to join
- Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
- ECOG score 0~1,age 18~70 years old
- Expected survival over 6 months
- The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
- CBC：Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
- Serum ALT≤2×UL, AST≤2×ULN；Serum creatinine≤1.5×ULN；
Who cannot join
- Activity or uncontrol severe infection
- Liver cirrhosis, Decompensated liver disease
- History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
- Chronic renal insufficiency or renal failure
- Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
- Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Dongling Zou, M.D., +8613657690699, cqzl_zdl@163.com
About this study
Official title: Drug Screening of Patient-derived Organoids From Ovarian Cancer Culture to Personalized Therapy,an Exploratory Research
The tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC) patients.
Read the detailed description
Tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.Ovarian cancer(OC) organoids will be then cultured. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and immunohistochemistry (TP53, PAX8 etc). After then, the patient-derived organoids cultured from OC will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by NCCN guidlines versus patients treated in clinical practice.
- Conditions
- Ovarian Cancer
- Being tested
- no intervention
- Keywords
- tumor organoids, drug sensitivity, precision treatment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
It is an observation trial.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 5 years
OS
Overall survival
Measured: 5 years
Secondary outcomes (2)
ORR
CR+PR
Measured: 1 year
DCR
CR+PR+SD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start12 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongling Zou, Chongqing University Cancer Hospital
- Investigators
- Dongling Zou, M.D., Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768270
- Sponsor's protocol ID
- CQGOG0201
- Status last verified
- Aug 2023
- First submitted
- 20 Feb 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Screening of Patient-derived Organoids From Ovarian Cancer Culture to Personalized Therapy,an Exploratory Research
- ClinicalTrials.gov ID
- NCT04768270
- Acronym / sponsor ID
- CQGOG0201
- Conditions
- Ovarian Cancer
- Keywords
- tumor organoids, drug sensitivity, precision treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Feb 2021 (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 tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC) patients.
Detailed description
Tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.Ovarian cancer(OC) organoids will be then cultured. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and immunohistochemistry (TP53, PAX8 etc). After then, the patient-derived organoids cultured from OC will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by NCCN guidlines versus patients treated in clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- ovarian cancer patients who accept primary cytoreductive surgery
Key inclusion criteria (6 listed)
- Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
- ECOG score 0~1,age 18~70 years old
- Expected survival over 6 months
- The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
- CBC：Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
Key exclusion criteria (7 listed)
- Activity or uncontrol severe infection
- Liver cirrhosis, Decompensated liver disease
- History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
- Chronic renal insufficiency or renal failure
- Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
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 |
|---|---|---|
| no interventionIt is an observation trial. | Other | – |
Primary outcome
PFS
Time frame: 5 years
Progression-free survival
OS
Time frame: 5 years
Overall survival
2 secondary outcomes
ORR
Time frame: 1 year
DCR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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.
Dongling Zou, M.D. principal investigator
Chongqing University Cancer 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 Ovarian Cancer, run by Chongqing University Cancer 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 7 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 31 Aug 2023. 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 Dongling Zou, M.D. (+8613657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 5 years). 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 31 Aug 2023.