CarcinomaNCT02696525
Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients
An observational study of Carcinoma and Non-small-cell Lung Cancer, run by Peking University People's Hospital at 3 sites in China.
Trial summary
Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms
- How many people
- 145 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2018to Dec 2021
- How long will I take part?
- 3 Years
- 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: 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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Kezhong Chen, M.D., +8613488752289, mdkzchen@163.com
Lixin Zhou, M.D., +8613811264336, zhoulixin04@sina.com
Guang Dong General Hospital, Thoracic Surgery
Guangzhou, Guangdong, 510080
Xuening Yang, M.D.
Wenzhao Zhong, M.D.
Jiang Su Cancer Hospital
Nanjing, Jiangsu, 210009
Feng Yin, M.D.
Lin Xu, M.D.
About this study
Official title: A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients
Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.
Read the detailed description
Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.
We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.
- Conditions
- Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms
- Keywords
- Circulating Tumor DNA, Lung cancer, lead time
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
Measured: 4 years
Secondary outcomes (5)
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers
Measured: 4 years
The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample
Measured: 1 year
Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis
Measured: 4 years
Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis
Measured: 4 years
CtDNA predictive value between locoregional recurrence and distant metastasis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- San Valley Biotechnology Incorporated
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, M.D., Principal investigator, Peking University People's HospitalYilong Wu, M.D., Study chair, Guang Dong General HospitalLin Xu, M.D., Study director, Jiang Su Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696525
- Sponsor's protocol ID
- PTHO1601
- Status last verified
- May 2018
- First submitted
- 25 Feb 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. 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 Stage ⅢA Non-small-cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02696525
- Acronym / sponsor ID
- PTHO1601
- Conditions
- Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms
- Keywords
- Circulating Tumor DNA, Lung cancer, lead time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- San Valley Biotechnology Incorporated
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- 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 confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.
Detailed description
Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.
We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
Time frame: 4 years
5 secondary outcomes
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers
Time frame: 4 years
The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample
Time frame: 1 year
Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis
Time frame: 4 years
Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis
Time frame: 4 years
CtDNA predictive value between locoregional recurrence and distant metastasis
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jun Wang, M.D. principal investigator
Peking University People's Hospital
Yilong Wu, M.D. study chair
Guang Dong General Hospital
Lin Xu, M.D. study director
Jiang Su Cancer Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma and Non-small-cell Lung Cancer, run by Peking University People's Hospital at 3 sites 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 6 inclusion and 7 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Kezhong Chen, M.D. (（+86）13488752289, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches (time frame: 4 years). 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 21 May 2018.