Epithelial Ovarian CancerNCT06315270
To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer
An observational study of Epithelial Ovarian Cancer and Stage III Ovarian Cancer, run by The First Hospital of Jilin University.
Trial summary
This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 20 Mar 2029
- How long will I take part?
- 5 Years
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: advanced EOC
Who may be able to join
- Newly diagnosed patients with advanced EOC, 18-75 years of age: including patients with preoperative assessment of stage III-IV EOC, who underwent initial tumour cytoreduction and 6-8 courses of postoperative chemotherapy with paclitaxel + carboplatin/docetaxel + carboplatin;
- Eastern Cooperative Oncology Group (ECOG) physical strength status (PS) score of 0 or 1;
- Cooperation in the treatment process by providing clinicopathological data and imaging data required for the study process;
- Cooperate with follow-up visits and collection of node blood for clinical efficacy assessment, and agree to use the test data for subsequent research and product development.
- The initial and follow-up treatment processes are in accordance with NCCN guidelines;
Who cannot join
- Neoadjuvant chemotherapy patients;
- Splenectomy patients;
- Patients with contraindications to radiotherapy;
- Any other patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study;
- Unacceptable or unavailable means of assessing specified efficacy such as imaging;
- Vaccination within 2 months; antibiotics for infection within 2 weeks; history of blood transfusion within 2 weeks;
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- Long-term use of recombinant human erythropoietin, recombinant human interleukin, Ricodin tablets and other drugs affecting the composition of blood cells;
- Severe organ dysfunction;
- Infectious diseases such as immunodeficiency syndrome, active tuberculosis, HIV infection, and other infectious diseases not suitable for participation;
- Pre-cancerous diseases of the blood, such as myelodysplastic syndromes;
- Have received immunosuppressive therapy within 2 weeks;
- Suffering from blood clotting disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis.
- Keywords
- TCR, Immunological monitoring
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of TCR genealogy data
- Analysis of TCRα and TCRβ profile profiles in advanced EOC patients before initial treatment;
- Analysis of differences in diversity of TCRα and TCRβ profiles in advanced EOC patients before treatment, after completion of treatment and at relapse;
- Analysis of longitudinal TCR profiles revealing the stability and individual specificity of the immune profiles;
- correlation of TCRα and TCRβ profiling diversity with levels of tumour markers (ca125, ca199, CEA, HE-4) and imaging findings under continuous monitoring to explore their value in monitoring tumour treatment response
- Differential analysis of dynamic changes in TCRα profile and TCRβ profile in correlation with patients' clinical outcomes
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 posted18 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completion20 Mar 2029 (estimated)
- Study completion20 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315270
- Sponsor's protocol ID
- 24K040-001
- Status last verified
- Jan 2024
- First submitted
- 11 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06315270
- Acronym / sponsor ID
- 24K040-001
- Keywords
- TCR, Immunological monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 20 Mar 2029 (estimated)
- Study completion
- 20 Mar 2029 (estimated)
- First posted
- 18 Mar 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 project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced EOC
Key inclusion criteria (5 listed)
- Newly diagnosed patients with advanced EOC, 18-75 years of age: including patients with preoperative assessment of stage III-IV EOC, who underwent initial tumour cytoreduction and 6-8 courses of postoperative chemotherapy with paclitaxel + carboplatin/docetaxel + carboplatin;
- Eastern Cooperative Oncology Group (ECOG) physical strength status (PS) score of 0 or 1;
- Cooperation in the treatment process by providing clinicopathological data and imaging data required for the study process;
- Cooperate with follow-up visits and collection of node blood for clinical efficacy assessment, and agree to use the test data for subsequent research and product development.
- The initial and follow-up treatment processes are in accordance with NCCN guidelines;
Key exclusion criteria (12 listed)
- Neoadjuvant chemotherapy patients;
- Splenectomy patients;
- Patients with contraindications to radiotherapy;
- Any other patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study;
- Unacceptable or unavailable means of assessing specified efficacy such as imaging;
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
Analysis of TCR genealogy data
Time frame: 5 years
1. Analysis of TCRα and TCRβ profile profiles in advanced EOC patients before initial treatment; 2. Analysis of differences in diversity of TCRα and TCRβ profiles in advanced EOC patients before treatment, after completion of treatment and at relapse; 3. Analysis of longitudinal TCR profiles revealing the stability and individual specificity of the immune profiles; 4. correlation of TCRα and TCRβ profiling diversity with levels of tumour markers (ca125, ca199, CEA, HE-4) and imaging findings under continuous monitoring to explore their value in monitoring tumour treatment response 5. Differential analysis of dynamic changes in TCRα profile and TCRβ profile in correlation with patients' clinical outcomes
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 1 Apr 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer and Stage III Ovarian Cancer, run by The First Hospital of Jilin University.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact zhentong wei, doctor (15804300686, zhentongwei2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of TCR genealogy data (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 1 Apr 2024.