Ovarian CancerNCT06483425
A Biomarker Exploration Study of Precision Treatment in Ovarian Cancer
An observational study of Ovarian Cancer and Biomarker, run by Tongji Hospital at 1 site in China.
Trial summary
This clinical trial aims to investigate the role of biomarkers in guiding precision treatment for ovarian cancer. The study will explore the effectiveness of personalized treatment strategies based on specific biomarkers identified in ovarian cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer, Biomarker
- What is being tested?
- Sequencing of DNA, RNA, and Proteins
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Ovarian cancer, who are willing to participate in this study and agree to donate samples for sequencing could be included.
Who may be able to join
- Patients diagnosed with ovarian cancer.
- Willingness to undergo biomarker testing.
- Ability to provide informed consent for participation in the study.
Who cannot join
- Inability to comply with study requirements or follow-up visits.
- Previous participation in a conflicting clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
This clinical trial aims to investigate the role of biomarkers in guiding precision treatment for ovarian cancer. The study will explore the effectiveness of personalized treatment strategies based on specific biomarkers identified in ovarian cancer patients. By analyzing the correlation between biomarker profiles and treatment outcomes, the trial seeks to optimize treatment decisions and improve overall survival rates in ovarian cancer patients.
- Conditions
- Ovarian Cancer, Biomarker
- Being tested
- Sequencing of DNA, RNA, and Proteins
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequencing of DNA, RNA, and ProteinsGenetic
Sequencing of DNA, RNA, and Proteins for Tumor, Blood, Ascite, and other samples before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer pateitns | Patients diagnosed with Ovarian cancer in Tongji Hospital, Wuhan. Receives: Genetic: Sequencing of DNA, RNA, and Proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker explorarion
Blood, tumor, and other samples should be sequenced by RNA-seq, Next-Generation Sequencing, or proteomics to identify specific biomarkers associated with treatment response and prognosis in ovarian cancer.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (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 Tongji HospitalThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483425
- Sponsor's protocol ID
- 2024-TJ-OCBiomarker
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker Exploration Study of Precision Treatment in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06483425
- Acronym / sponsor ID
- 2024-TJ-OCBiomarker
- Conditions
- Ovarian Cancer, Biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Jul 2024 (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 clinical trial aims to investigate the role of biomarkers in guiding precision treatment for ovarian cancer. The study will explore the effectiveness of personalized treatment strategies based on specific biomarkers identified in ovarian cancer patients. By analyzing the correlation between biomarker profiles and treatment outcomes, the trial seeks to optimize treatment decisions and improve overall survival rates in ovarian cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer pateitns | – | Genetic: Sequencing of DNA, RNA, and ProteinsPatients diagnosed with Ovarian cancer in Tongji Hospital, Wuhan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Ovarian cancer, who are willing to participate in this study and agree to donate samples for sequencing could be included.
Key inclusion criteria (3 listed)
- Patients diagnosed with ovarian cancer.
- Willingness to undergo biomarker testing.
- Ability to provide informed consent for participation in the study.
Key exclusion criteria (2 listed)
- Inability to comply with study requirements or follow-up visits.
- Previous participation in a conflicting clinical trial.
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 DNA, RNA, and ProteinsSequencing of DNA, RNA, and Proteins for Tumor, Blood, Ascite, and other samples before and after treatment. | Genetic | Ovarian cancer pateitns |
Primary outcome
Biomarker explorarion
Time frame: 5 years
Blood, tumor, and other samples should be sequenced by RNA-seq, Next-Generation Sequencing, or proteomics to identify specific biomarkers associated with treatment response and prognosis in ovarian cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Biomarker, run by Tongji 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 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker explorarion (time frame: 5 years). 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 Jul 2024.