CarcinomaMEDALNCT03634826
Monitoring of Circulating Tumor DNA and Its Aberrant Methylation in the Surveillance of Surgical Lung Cancer Patients (MEDAL, MEthylation Based Dynamic Analysis for Lung Cancer).
An observational study of Carcinoma and Lung Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Lung Cancer, NSCLC
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 1 Jan 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed lung cancer patients who received surgical therapy
Who may be able to join
- Aged 18 to 80 years
- Lung cancer was suspected preoperatively.
- Received curative surgical therapy
- No malignant tumor history within the past 5 years
- No being received any treatment prior to resection
- Patients must have given written informed consent
Who cannot join
- The pulmonary nodule is pure ground glass opacity
- Unable to comply with the study procedure
- The postoperative pathology is not NSCLC.
- Unqualified blood samples
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Kezhong Chen, M.D., +8613488752289, mdkzchen@163.com
About this study
Official title: A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation
Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.
Read the detailed description
Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients.
The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.
- Conditions
- Carcinoma, Lung Cancer, NSCLC, Lung Neoplasm
- Keywords
- circulating tumor DNA, ctDNA methylation, lung cancer, surveillance
- Medical subject headings
- Carcinoma, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.
Measured: 3 years
Secondary outcomes (4)
The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.
Concordance will be defined as matched ctDNA and tumor DNA has the same identified mutations (methylation status alterations) or has no mutation (methylation status alteration). Concordance rate (%) will be calculated by consistent patient number and total patient number.
Measured: 1 year
The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.
Measured: 1 year
Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.
Measured: 3 years
Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Aug 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, M.D., Study chair, Peking University People's Hospital Thoracic Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634826
- Sponsor's protocol ID
- PTHO1802
- Acronym
- MEDAL
- Status last verified
- Jun 2020
- First submitted
- 5 Aug 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen K, Kang G, Zhang Z, Lizaso A, Beck S, Lyskjaer I, Chervova O, Li B, Shen H, Wang C, Li B, Zhao H, Li X, Yang F, Kanu N, Wang J. Individualized dynamic methylation-based analysis of cell-free DNA in postoperative monitoring of lung cancer. BMC Med. 2023 Jul 14;21(1):255. doi: 10.1186/s12916-023-02954-z.
PubMed 37452374Kang G, Chen K, Yang F, Chuai S, Zhao H, Zhang K, Li B, Zhang Z, Wang J. Monitoring of circulating tumor DNA and its aberrant methylation in the surveillance of surgical lung Cancer patients: protocol for a prospective observational study. BMC Cancer. 2019 Jun 13;19(1):579. doi: 10.1186/s12885-019-5751-9.
PubMed 31195991
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation
- ClinicalTrials.gov ID
- NCT03634826
- Acronym / sponsor ID
- MEDAL / PTHO1802
- Conditions
- Carcinoma, Lung Cancer, NSCLC, Lung Neoplasm
- Keywords
- circulating tumor DNA, ctDNA methylation, lung cancer, surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 17 Aug 2018 (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.
Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.
Detailed description
Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients.
The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed lung cancer patients who received surgical therapy
Key inclusion criteria (6 listed)
- Aged 18 to 80 years
- Lung cancer was suspected preoperatively.
- Received curative surgical therapy
- No malignant tumor history within the past 5 years
- No being received any treatment prior to resection
Key exclusion criteria (4 listed)
- The pulmonary nodule is pure ground glass opacity
- Unable to comply with the study procedure
- The postoperative pathology is not NSCLC.
- Unqualified blood samples
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
Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.
Time frame: 3 years
4 secondary outcomes
The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.
Time frame: 1 year
The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.
Time frame: 1 year
Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.
Time frame: 3 years
Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 37452374Chen K, Kang G, Zhang Z, Lizaso A, Beck S, Lyskjaer I, Chervova O, Li B, Shen H, Wang C, Li B, Zhao H, Li X, Yang F, Kanu N, Wang J. Individualized dynamic methylation-based analysis of cell-free DNA in postoperative monitoring of lung cancer. BMC Med. 2023 Jul 14;21(1):255. doi: 10.1186/s12916-023-02954-z.
- Derived from this study: PubMed 31195991Kang G, Chen K, Yang F, Chuai S, Zhao H, Zhang K, Li B, Zhang Z, Wang J. Monitoring of circulating tumor DNA and its aberrant methylation in the surveillance of surgical lung Cancer patients: protocol for a prospective observational study. BMC Cancer. 2019 Jun 13;19(1):579. doi: 10.1186/s12885-019-5751-9.
Related trials for Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
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.
Jun Wang, M.D. study chair
Peking University People's Hospital Thoracic Surgery Department
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 Lung Cancer, run by Peking University People's 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 6 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 26 Jun 2020. 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?
Contact Kezhong Chen, M.D. ((+86)13488752289, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634826, which also lists 2 linked publications.
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 26 Jun 2020.