HCCNCT05458115
Clinical Study of MRD Recurrence Monitoring After Surgical Resection of Hepatocellular Carcinoma
An observational study of HCC, run by Anhui Provincial Hospital.
Trial summary
ctDNA-based liquid biopsy can better detect the presence of MRD before imaging and serological markers, and is suitable for postoperative MRD and recurrence monitoring, which has been clinically validated in several cancer types such as lung cancer and intestinal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients
Who may be able to join
- understood and agreed to follow the study requirements, were willing to provide samples for testing, and signed an informed consent form.
- age 18-75 years, regardless of gender.
- patients with a clinical diagnosis of surgically resectable CNLC Ia-IIa hepatocellular carcinoma.
- patients who have not received any previous treatment for their primary treatment and who agree to receive treatment
- an ECOG physical status of 0 or 1 within 1 week prior to enrollment.
- have at least one measurable lesion according to RECIST v1.1 or mRECIST criteria and have not received radiation therapy
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- an expected survival time of ≥ 3 months.
- adequate organ function, with the following laboratory test values required within 7 days prior to treatment: - Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L, and white blood cell count ≥ 3 × 109/L.
- Note: Patients should not have received blood transfusion or growth factor support within 14 days prior to blood sample collection.
- International normalized ratio (INR) ≤ 1.5 times the upper limit of normal (1.5 x ULN).
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
- Total serum bilirubin ≤ 1.5 x ULN (patients with Gilbert syndrome may be enrolled if total bilirubin < 3 x ULN).
- Glutathione aminotransferase (AST) and glutathione alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- Renal function: serum creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min according to Cockcroft-Gault formula
Who cannot join
- patients with comorbid other active malignancies.
- active infection or known human immunodeficiency virus infection (HIV-positive).
- previous allogeneic stem cell transplantation.
- the patient's compliance during the study period is, in the judgment of the investigator, inadequate
- having received any systemic antineoplastic therapy prior to initiation of study treatment with approved
- has received blood transfusion, radiotherapy, or drug therapy within 1 month prior to enrollment.
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- untreated active hepatitis C (patients with positive anti-HCV antibodies or positive HCV RNA cannot be enrolled); untreated active hepatitis B (HBsAg positive and HBV DNA ≥ 2000 IU/mL).
- patients with hepatocellular carcinoma in whom distant metastases, vascular invasion and cancer emboli have been observed on imaging
- women of childbearing age with positive blood pregnancy tests
- subjects with a history of serious systemic disease such as diabetes, hypertension, myocardial infarction, etc., or other reasons believed to interfere with the accuracy of the test, or a combination of serious mental illness, in the opinion of the investigator.
About this study
ctDNA-based liquid biopsy can better detect the presence of MRD before imaging and serological markers, and is suitable for postoperative MRD and recurrence monitoring, which has been clinically validated in several cancer types such as lung cancer and intestinal cancer. However, there is no systematic comparative study of postoperative MRD and recurrence monitoring based on ctDNA testing in hepatocellular carcinoma. A prospective multicenter observational clinical study is proposed to evaluate the use of liquid biopsy based on ctDNA NGS assay in surgical evaluation, MRD and molecular recurrence state monitoring after radical resection of hepatocellular carcinoma, and to compare with imaging and serological findings with the aim of early detection of disease recurrence or metastasis and more survival benefits for patients.
- Conditions
- HCC
- Being tested
- Liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Patient underwent hepatic R0 resection within a week
| Study group | Role | What they receive |
|---|---|---|
| liver resection group | Not described Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinicopathological information recording
Age, gender, ECOG PS, Child-pugh, tumor stage, cirrhosis, history of hepatitis
Measured: 2 years
Adverse effect
Incidence of adverse reactions after various treatments
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 posted14 Jul 2022
- Study start30 Sep 2022 (estimated)
- 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 HCCStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458115
- Sponsor's protocol ID
- kyMRD
- Status last verified
- Jul 2022
- First submitted
- 16 Sep 2021
- Last updated
- 14 Jul 2022
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of MRD Recurrence Monitoring After Surgical Resection of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05458115
- Acronym / sponsor ID
- kyMRD
- Conditions
- HCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jul 2022 (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.
ctDNA-based liquid biopsy can better detect the presence of MRD before imaging and serological markers, and is suitable for postoperative MRD and recurrence monitoring, which has been clinically validated in several cancer types such as lung cancer and intestinal cancer. However, there is no systematic comparative study of postoperative MRD and recurrence monitoring based on ctDNA testing in hepatocellular carcinoma. A prospective multicenter observational clinical study is proposed to evaluate the use of liquid biopsy based on ctDNA NGS assay in surgical evaluation, MRD and molecular recurrence state monitoring after radical resection of hepatocellular carcinoma, and to compare with imaging and serological findings with the aim of early detection of disease recurrence or metastasis and more survival benefits for patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver resection group | – | Procedure: Liver resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients
Key inclusion criteria (14 listed)
- understood and agreed to follow the study requirements, were willing to provide samples for testing, and signed an informed consent form.
- age 18-75 years, regardless of gender.
- patients with a clinical diagnosis of surgically resectable CNLC Ia-IIa hepatocellular carcinoma.
- patients who have not received any previous treatment for their primary treatment and who agree to receive treatment
- an ECOG physical status of 0 or 1 within 1 week prior to enrollment.
Key exclusion criteria (10 listed)
- patients with comorbid other active malignancies.
- active infection or known human immunodeficiency virus infection (HIV-positive).
- previous allogeneic stem cell transplantation.
- the patient's compliance during the study period is, in the judgment of the investigator, inadequate
- having received any systemic antineoplastic therapy prior to initiation of study treatment with approved
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 |
|---|---|---|
| Liver resectionPatient underwent hepatic R0 resection within a week | Procedure or surgery | liver resection group |
Primary outcome
clinicopathological information recording
Time frame: 2 years
Age, gender, ECOG PS, Child-pugh, tumor stage, cirrhosis, history of hepatitis
Adverse effect
Time frame: 2 years
Incidence of adverse reactions after various treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Anhui Provincial Hospital.
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 14 inclusion and 10 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 14 Jul 2022. 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?
Results are not available in the source record.
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?
clinicopathological information recording (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 14 Jul 2022.