NCT03634826

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

August 5, 2018

Last Update Submit

June 24, 2020

Conditions

CarcinomaLung CancerNSCLCLung Neoplasm

Keywords

circulating tumor DNActDNA methylationlung cancersurveillance

Outcome Measures

Primary Outcomes (1)

  • Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.

    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.

    1 year

  • The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.

    1 year

  • Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.

    3 years

  • Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.

    3 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histologically confirmed lung cancer patients who received surgical therapy

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37452374DERIVED

  • 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.

    PMID: 31195991DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue and blood samples were collected from each patient. Time for blood sample collection: 1) Preoperation. 2) The 3rd day of postoperation. 3) Regular follow-up.

MeSH Terms

Conditions

CarcinomaLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Wang, M.D.

    Peking University People's Hospital Thoracic Surgery Department

    STUDY CHAIR

Central Study Contacts

Kezhong Chen, M.D.

CONTACT

(+86)13488752289mdkzchen@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief，Thoracic Surgery Service

Study Record Dates

First Submitted

August 5, 2018

First Posted

August 17, 2018

Study Start

August 15, 2018

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

June 26, 2020

Record last verified: 2020-06

Locations

CN(1)