CarcinomaNCT05917106
Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
An observational study of Carcinoma and Renal Cell Carcinoma, run by Jinling Hospital, China at 1 site in China.
Trial summary
To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Renal Cell Carcinoma, RCC
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2022to Jun 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: RCC patients undergoing surgical treatment
Who may be able to join
- Newly diagnosed renal cell carcinoma
- Without any treatment
- Agree and accept radical surgical treatment
- Signed written informed consent
- ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1
- Follow up protocol and related procedures
Who cannot join
- Had other cancers
- Had received any antitumor therapy before
- Known or suspected active autoimmune disease
- Informed consent is not possible due to medical or psychiatric problems
- Have clinical symptoms or diseases of the heart that are not well controlled
- Patients judged by the investigators to be unsuitable for inclusion in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, 210000
Le Qu, M.D., 15720625951, septsoul@hotmail.com
About this study
To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.
Read the detailed description
Some studies have shown the potential of ctDNA in renal cancer monitoring, but the amount of ctDNA released in renal cancer is the lowest among non-cranial tumors. Even in advanced patients, the detection rate of tumor system mutation is less than 50%. DNA methylation is important in the process of tumor occurrence and development. However, no studies have focused on the value of ctDNA methylation in monitoring renal cancer, nor have large prospective cohort studies been conducted in patients with renal cancer.
This study intended to analyze the dynamic changes of circulating tumor DNA and its methylation status in patients with kidney cancer from preoperative to long-term follow-up, and to compare the evaluation value of methylation detection with traditional imaging examination and traditional blood tumor markers in the monitoring process.
- Conditions
- Carcinoma, Renal Cell Carcinoma, RCC, Kidney Neoplasms, Kidney Cancer
- Medical subject headings
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.
Measured: 5 years
To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.
Measured: 5 years
The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.
Measured: 5 years
A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics
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 posted23 Jun 2023
- Study start26 Dec 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- 450 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917106
- Sponsor's protocol ID
- 2023DZKY-039-01
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2023
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)
- ClinicalTrials.gov ID
- NCT05917106
- Acronym / sponsor ID
- 2023DZKY-039-01
- Conditions
- Carcinoma, Renal Cell Carcinoma, RCC, Kidney Neoplasms, Kidney Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 23 Jun 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.
To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.
Detailed description
Some studies have shown the potential of ctDNA in renal cancer monitoring, but the amount of ctDNA released in renal cancer is the lowest among non-cranial tumors. Even in advanced patients, the detection rate of tumor system mutation is less than 50%. DNA methylation is important in the process of tumor occurrence and development. However, no studies have focused on the value of ctDNA methylation in monitoring renal cancer, nor have large prospective cohort studies been conducted in patients with renal cancer.
This study intended to analyze the dynamic changes of circulating tumor DNA and its methylation status in patients with kidney cancer from preoperative to long-term follow-up, and to compare the evaluation value of methylation detection with traditional imaging examination and traditional blood tumor markers in the monitoring process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- RCC patients undergoing surgical treatment
Key inclusion criteria (6 listed)
- Newly diagnosed renal cell carcinoma
- Without any treatment
- Agree and accept radical surgical treatment
- Signed written informed consent
- ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1
Key exclusion criteria (6 listed)
- Had other cancers
- Had received any antitumor therapy before
- Known or suspected active autoimmune disease
- Informed consent is not possible due to medical or psychiatric problems
- Have clinical symptoms or diseases of the heart that are not well controlled
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
To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma.
Time frame: 5 years
To explore the advance time of ctDNA methylomics in monitoring postoperative recurrence of renal cancer compared with imaging.
Time frame: 5 years
The molecular mechanism of renal cancer recurrence was analyzed with baseline tissue and circulating methylation profiles.
Time frame: 5 years
A renal cancer recurrence risk model was established based on clinical information, molecular risk factors and ctDNA methylomics
Time frame: 5 years
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 11 Dec 2025.
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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.
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 Carcinoma and Renal Cell Carcinoma, run by Jinling Hospital, China 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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?
Contact Le Qe, M.D. (15720625951, septsoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the predictive effect of ctDNA methylomics on the prognosis and medication guidance of renal carcinoma. (time frame: 5 years). The study lists 4 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 11 Dec 2025.