NCT03081741

Brief Summary

Conduct a prospective study to detect the change of ctDNA 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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

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

March 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

March 12, 2017

Last Update Submit

May 22, 2017

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Effect of surgery on ctDNA of lung cancer patients

    Changes of blood ctDNA of lung cancer patients before and after surgery.

    before surgery and 7days after surgery

Eligibility Criteria

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

Surgical lung cancer patients.

You may qualify if:

  • Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent

You may not qualify if:

  • Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

RECRUITING

Related Publications (1)

  • Peng M, Xie Y, Li X, Qian Y, Tu X, Yao X, Cheng F, Xu F, Kong D, He B, Liu C, Cao F, Yang H, Yu F, Xu C, Tian G. Resectable lung lesions malignancy assessment and cancer detection by ultra-deep sequencing of targeted gene mutations in plasma cell-free DNA. J Med Genet. 2019 Oct;56(10):647-653. doi: 10.1136/jmedgenet-2018-105825. Epub 2019 Apr 13.

    PMID: 30981987DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and FFPE tissue sections were collected from each patient.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Geng Tian, MD

    Shenzhen Second People's Hospital

    STUDY CHAIR

Central Study Contacts

Chaoyu Liu, PhD

CONTACT

+8675588858978-808lcy@genehe.com

Xiaohua Li, PhD

CONTACT

+8675588858978-808lixiaohua@genehe.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2017

First Posted

March 16, 2017

Study Start

May 3, 2017

Primary Completion

December 1, 2017

Study Completion

March 18, 2020

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)