NCT02696525

Brief Summary

Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell 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
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

February 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
2.8 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

February 25, 2016

Last Update Submit

May 17, 2018

Conditions

CarcinomaNon-small-cell Lung CancerLung Neoplasms

Keywords

Circulating Tumor DNALung cancerlead time

Outcome Measures

Primary Outcomes (1)

  • Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches

    4 years

Secondary Outcomes (5)

  • Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers

    4 years

  • The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample

    1 year

  • Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis

    4 years

  • Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis

    4 years

  • CtDNA predictive value between locoregional recurrence and distant metastasis

    4 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 stage ⅢA non-small cell lung cancer patients who have the same driver mutation in tumor tissue and circulating tumor DNA(blood or urine)

You may qualify if:

  • Aged 18 to 80 years
  • Undergo radical surgery（R0 resection）
  • Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
  • Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
  • Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
  • Patients must have given written informed consent

You may not qualify if:

  • Unable to comply with the study procedure
  • Malignant tumor history within the past 5 years
  • Patients who received any treatment prior to resection
  • R1 or R2 resection
  • Coexisting small cell lung cancer
  • Received target drug therapy after surgery
  • Unqualified blood or urine samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Guang Dong General Hospital, Thoracic Surgery

Guangzhou, Guangdong, 510080, China

Location

Jiang Su Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue, urine samples and blood samples were collected from each patient. Time:Preoperative, 3 days and 3、6、12、18、24、30、36 months after surgery.

MeSH Terms

Conditions

CarcinomaCarcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Wang, M.D.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • Yilong Wu, M.D.

    Guang Dong General Hospital

    STUDY CHAIR

  • Lin Xu, M.D.

    Jiang Su Cancer Hospital

    STUDY DIRECTOR

Central Study Contacts

Kezhong Chen, M.D.

CONTACT

（+86）13488752289mdkzchen@163.com

Lixin Zhou, M.D.

CONTACT

（+86）13811264336zhoulixin04@sina.com

Study Design

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

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 2, 2016

Study Start

December 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

CN(3)