Lung NeoplasmsNCT03081741
Circulating Tumor DNA in Surgical Lung Cancer Patients
An observational study of Lung Neoplasms, run by Shenzhen Gene Health Bio Tech Co., Ltd. at 1 site in China.
Trial summary
Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2017to 18 Mar 2020
- 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: Surgical lung cancer patients.
Who may be able to join
- 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
Who cannot join
- Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Geng Tian, MD, tiangeng666@aliyun.com
Chaoyu Liu, PhD, lcy@genehe.com
About this study
Official title: A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Lung Cancer Patients
Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.
Read the detailed description
Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.
The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.
- Conditions
- Lung Neoplasms
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of surgery on ctDNA of lung cancer patients
Changes of blood ctDNA of lung cancer patients before and after surgery.
Measured: before surgery and 7days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start3 May 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion18 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Gene Health Bio Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen People's Hospital, Shenzhen Second People's Hospital, Peking University Shenzhen Hospital
- Responsible party
- Sponsor
- Investigators
- Geng Tian, MD, Study chair, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081741
- Sponsor's protocol ID
- GeneHealth-LC-01
- Status last verified
- May 2017
- First submitted
- 12 Mar 2017
- Last updated
- 23 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30981987
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT03081741
- Acronym / sponsor ID
- GeneHealth-LC-01
- Conditions
- Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shenzhen Gene Health Bio Tech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen People's Hospital, Shenzhen Second People's Hospital, Peking University Shenzhen Hospital
- Study start
- 3 May 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 18 Mar 2020 (estimated)
- First posted
- 16 Mar 2017 (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 detect the change of ctDNA of surgical lung cancer patients.
Detailed description
Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.
The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical lung cancer patients.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection 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
Effect of surgery on ctDNA of lung cancer patients
Time frame: before surgery and 7days after surgery
Changes of blood ctDNA of lung cancer patients before and after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 30981987Peng 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.
- Individual participant dataSharing planned: No
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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.
Geng Tian, MD study chair
Shenzhen Second People's Hospital
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 Lung Neoplasms, run by Shenzhen Gene Health Bio Tech Co., Ltd. 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 1 inclusion and 1 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 23 May 2017. 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 Chaoyu Liu, PhD (+8675588858978-808, lcy@genehe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of surgery on ctDNA of lung cancer patients (time frame: before surgery and 7days after surgery). 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 NCT03081741, which also lists 1 linked publication.
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 23 May 2017.