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).

NCT ID: NCT03634826

Last Updated: 2020-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-15

Study Completion Date

2022-01-01

Brief Summary

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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

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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

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Carcinoma Lung Cancer NSCLC Lung Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* The pulmonary nodule is pure ground glass opacity
* Unable to comply with the study procedure
* The postoperative pathology is not NSCLC.
* Unqualified blood samples
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

Chief,Thoracic Surgery Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Wang, M.D.

Role: STUDY_CHAIR

Peking University People's Hospital Thoracic Surgery Department

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kezhong Chen, M.D.

Role: CONTACT

(+86)13488752289

Facility Contacts

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Kezhong Chen, M.D.

Role: primary

+8613488752289

References

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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.

Reference Type DERIVED
PMID: 37452374 (View on PubMed)

Kang 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.

Reference Type DERIVED
PMID: 31195991 (View on PubMed)

Other Identifiers

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PTHO1802

Identifier Type: -

Identifier Source: org_study_id

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