Preoperative and Postoperative ctDNA Comparison in Early Stage Lung CnacerNCT03805256
Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer
An observational study of Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2018to 30 Jun 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population comprises all adult patients aged 18 years and older who present with pulmonary nodules.The study sample will include 60 subjects.
Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection were able to enter the study -
Exclusion Criteria:Patients who received any invasive examination or treatment prior to resection or had a history of malignancy; patients who do not attend follow up after surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung cancer in pathology。
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Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jianping Gong
Suzhou, Jiangsu, 215000
Jianping Gong, Doctor, 051267783834, gongjianpingsz@162.com
Mengqin Xu, Master, 18306202242, xumengqin77@163.com
About this study
Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。
What is being measured
The primary outcome is the main question the study is designed to answer.
The potential value of ctDNA in the diagnosis of NSCLC
The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer
Measured: Half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start14 May 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative and Postoperative ctDNA Comparison in Early Stage Lung CnacerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianping Gong, Doctor, Study director, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805256
- Sponsor's protocol ID
- 12345
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT03805256
- Acronym / sponsor ID
- 12345
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 15 Jan 2019 (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.
Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population comprises all adult patients aged 18 years and older who present with pulmonary nodules.The study sample will include 60 subjects.
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
The potential value of ctDNA in the diagnosis of NSCLC
Time frame: Half a year
The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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.
Jianping Gong, Doctor study director
Second Affiliated Hospital of Soochow University
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 Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer, run by Second Affiliated Hospital of Soochow University 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?
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 15 Jan 2019. 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 Jianping chief physician, Doctor (13701415049, gongjianpingsz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The potential value of ctDNA in the diagnosis of NSCLC (time frame: Half a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2019.