Endometrial CancerNCT06341855
Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer
A study testing MRD-ctDNA in people with Endometrial Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- MRD-ctDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 30 Jan 2026
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) endometrial carcinoma with high risk of recurrence after radical surgery: stage I G3 endometrioid carcinoma, serous carcinoma, clear cell carcinoma, carcinosarcoma, dedifferentiated / undifferentiated carcinoma, II-IV stage endometrial carcinoma, operable recurrent endometrial carcinoma.
- the physical status (PS) score of the eastern tumor tissue cooperation group (ECOG) was 0 or 1.
- the treatment process should cooperate with the provision of clinicopathological and imaging data needed for the research process.
- cooperate with the follow-up and collect the blood of the clinical curative effect evaluation node, and agree to use the test data for follow-up research and product development.
- after operation, imaging examination showed no evidence of local disease or distant metastasis.
Who cannot join
- (1) histological diagnosis of endometrial stromal sarcoma.
- there are contraindications of radiotherapy and chemotherapy.
- any other patients who may have poor compliance with the procedures and requirements of the study have been judged by the researchers.
- designated evaluation methods such as imaging can not be accepted or provided.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 1st hospital of Jilin University
Changchun, Jilin
Xiaosen Li Li, +8618343116682, xiaosensen@jlu.edu.cn
About this study
Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma.
Read the detailed description
High-risk EC has a higher metastasis and recurrence rate, accounting for only 20% of ECs, but accounting for 48% of tumor-related mortality. The prognosis of high-risk EC patients is still poor after standard treatment. Among the indicators for monitoring the recurrence of high-risk EC, the most commonly used tumor markers are CA125 and HE4, but these markers increase only in extrauterine metastasis and are less sensitive. Tumor tissue biopsy is an invasive operation, which can not reflect heterogeneity. In addition, continuous monitoring can not be achieved by one biopsy. Therefore, more sensitive, personalized and easily monitored markers are needed to predict recurrence and prognosis in order to provide individualized treatment. Patients after surgical treatment may have MRD, which is a potential source of subsequent early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be able to reliably detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. CtDNA-MRD is a reliable predictive biomarker in EC. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial cancer, using individualized customized strategy, according to the mutation sites in tumor pathological tissue NGS detection results, combined with cancer core genes, customized probes for each patient. To explore the feasibility of ctDNA-MRD in monitoring recurrence and evaluating prognosis of high-risk endometrial carcinoma. According to the treatment and non-treatment groups of ctDNA-MRD-positive patients after adjuvant therapy, to explore whether intensive treatment of ctDNA-MRD-positive patients with high-risk endometrial cancer after adjuvant therapy can significantly improve the survival benefits of patients
- Conditions
- Endometrial Cancer
- Being tested
- MRD-ctDNA
- Keywords
- MRD, Endometrial Cancer, ctDNA
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD-ctDNADiagnostic test
ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA positive | Other | If the ctDNA test result is positive, the subjects will be stratified to the treatment group or follow-up group at 1:1. Receives: Diagnostic Test: MRD-ctDNA |
| ctDNA negative | Other | If the ctDNA test result is negative, the subjects will belong to follow-up group Receives: Diagnostic Test: MRD-ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
monitoring recurrence and evaluating prognosis
The correlation between ctDNA-MRD status and DFS and 2-year DFS rate before, after, during and after adjuvant therapy.
Measured: 2 years
Treatment benefit
To evaluate whether intensive therapy for ctDNA-MRD-positive patients with high-risk endometrial carcinoma after adjuvant therapy can significantly improve the survival benefits of patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start25 Jan 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Geneplus-Beijing Co. Ltd.
- Responsible party
- Principal investigator, Songling Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341855
- Sponsor's protocol ID
- 23K294001
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2024
- Last updated
- 2 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06341855
- Acronym / sponsor ID
- 23K294001
- Conditions
- Endometrial Cancer
- Keywords
- MRD, Endometrial Cancer, ctDNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Geneplus-Beijing Co. Ltd.
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 2 Apr 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.
Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma.
Detailed description
High-risk EC has a higher metastasis and recurrence rate, accounting for only 20% of ECs, but accounting for 48% of tumor-related mortality. The prognosis of high-risk EC patients is still poor after standard treatment. Among the indicators for monitoring the recurrence of high-risk EC, the most commonly used tumor markers are CA125 and HE4, but these markers increase only in extrauterine metastasis and are less sensitive. Tumor tissue biopsy is an invasive operation, which can not reflect heterogeneity. In addition, continuous monitoring can not be achieved by one biopsy. Therefore, more sensitive, personalized and easily monitored markers are needed to predict recurrence and prognosis in order to provide individualized treatment. Patients after surgical treatment may have MRD, which is a potential source of subsequent early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be able to reliably detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. CtDNA-MRD is a reliable predictive biomarker in EC. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial cancer, using individualized customized strategy, according to the mutation sites in tumor pathological tissue NGS detection results, combined with cancer core genes, customized probes for each patient. To explore the feasibility of ctDNA-MRD in monitoring recurrence and evaluating prognosis of high-risk endometrial carcinoma. According to the treatment and non-treatment groups of ctDNA-MRD-positive patients after adjuvant therapy, to explore whether intensive treatment of ctDNA-MRD-positive patients with high-risk endometrial cancer after adjuvant therapy can significantly improve the survival benefits of patients
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA positive | Other | Diagnostic Test: MRD-ctDNAIf the ctDNA test result is positive, the subjects will be stratified to the treatment group or follow-up group at 1:1. |
| ctDNA negative | Other | Diagnostic Test: MRD-ctDNAIf the ctDNA test result is negative, the subjects will belong to follow-up group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1) endometrial carcinoma with high risk of recurrence after radical surgery: stage I G3 endometrioid carcinoma, serous carcinoma, clear cell carcinoma, carcinosarcoma, dedifferentiated / undifferentiated carcinoma, II-IV stage endometrial carcinoma, operable recurrent endometrial carcinoma.
Key exclusion criteria (4 listed)
- (1) histological diagnosis of endometrial stromal sarcoma.
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 |
|---|---|---|
| MRD-ctDNActDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC. | Diagnostic test | ctDNA negative, ctDNA positive |
Primary outcome
monitoring recurrence and evaluating prognosis
Time frame: 2 years
The correlation between ctDNA-MRD status and DFS and 2-year DFS rate before, after, during and after adjuvant therapy.
Treatment benefit
Time frame: 2 years
To evaluate whether intensive therapy for ctDNA-MRD-positive patients with high-risk endometrial carcinoma after adjuvant therapy can significantly improve the survival benefits of patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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. 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?
A study testing MRD-ctDNA in people with Endometrial Cancer, run by The First Hospital of Jilin 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 5 inclusion and 4 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 2 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monitoring recurrence and evaluating prognosis (time frame: 2 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 2 Apr 2024.