Tumor of Female Reproductive SystemNCT06018935
A Cohort Establishment Study of Total Management of Ovarian Cancer
An observational study of Tumor of Female Reproductive System and Ovarian Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
A cohort establishment study of total management of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tumor of Female Reproductive System, Ovarian Cancer
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2024to 1 Sep 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital
Who may be able to join
- Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital;
- Can cooperate with later follow-up.
Who cannot join
- Patients with other malignant tumors or previous history of other malignant tumors;
- Have cognitive impairment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu
Wang Dengfeng, Doctor, 15982222707, wonderful_96@163.com
About this study
Official title: A Cohort Establishment Study of Total Management of Ovarian Cancer (Including Fallopian Tube Cancer and Primary Peritoneal Cancer)
A cohort establishment study of total management of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).
Read the detailed description
- To investigate the effects of surgery, chemotherapy, maintenance therapy and related factors on the prognosis and quality of life of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer);
- To study the postoperative recovery of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer), perioperative complications, adverse reactions after chemotherapy, adverse reactions during targeted drug maintenance therapy, and explore possible effective preventive measures;
- The prognostic factors of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) were analyzed;
- To study the efficacy and safety of PARPi in clinical application in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).
- Being tested
- No intervention
- Keywords
- Ovarian cancer, Cohort study, Whole-process management
- Medical subject headings
- Genital Neoplasms, Female, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Freesurvival (PFS)
The time from the start of treatment until the patient progresses further or dies.
Measured: Average six months after study completion.
Overall Survival (OS)
Measure the time from the start of treatment to the time of death.
Measured: Average six months after study completion.
Secondary outcomes (1)
Occurrence of adverse reactions
All adverse events were recorded.
Measured: Average six months after study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start17 Jun 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of Female Reproductive SystemStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dengfeng Wang, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018935
- Sponsor's protocol ID
- LCATM202304
- Status last verified
- Jun 2024
- First submitted
- 10 Aug 2023
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Establishment Study of Total Management of Ovarian Cancer (Including Fallopian Tube Cancer and Primary Peritoneal Cancer)
- ClinicalTrials.gov ID
- NCT06018935
- Acronym / sponsor ID
- LCATM202304
- Keywords
- Ovarian cancer, Cohort study, Whole-process management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 31 Aug 2023 (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.
A cohort establishment study of total management of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).
Detailed description
- To investigate the effects of surgery, chemotherapy, maintenance therapy and related factors on the prognosis and quality of life of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer);
- To study the postoperative recovery of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer), perioperative complications, adverse reactions after chemotherapy, adverse reactions during targeted drug maintenance therapy, and explore possible effective preventive measures;
- The prognostic factors of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) were analyzed;
- To study the efficacy and safety of PARPi in clinical application in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital
Key inclusion criteria (2 listed)
- Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital;
- Can cooperate with later follow-up.
Key exclusion criteria (2 listed)
- Patients with other malignant tumors or previous history of other malignant tumors;
- Have cognitive impairment.
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 interventionNo intervention | Other | – |
Primary outcome
Progress Freesurvival (PFS)
Time frame: Average six months after study completion.
The time from the start of treatment until the patient progresses further or dies.
Overall Survival (OS)
Time frame: Average six months after study completion.
Measure the time from the start of treatment to the time of death.
1 secondary outcome
Occurrence of adverse reactions
Time frame: Average six months after study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- 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.
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 Tumor of Female Reproductive System and Ovarian Cancer, run by Sichuan Cancer Hospital and Research Institute 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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 Dengfeng Wang, Learned scholar (15982222707, wonderful_96@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Freesurvival (PFS) (time frame: Average six months after study completion.). 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 20 Jun 2024.