CarcinomaNCT02907606
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
An observational study of Carcinoma and Non-small-cell Lung Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC 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
- 45 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Aug 2020
- 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 non-small cell lung cancer patients with paired tumor tissue, peripheral blood samples, and urinary samples.
Who may be able to join
- Aged 18 to 80 years
- Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
- Completed and explicit information about TNM staging
- Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
- 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
- Coexisting small cell lung cancer
- Unqualified tissue, blood or urine samples
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People'S Hospital
Beijing, Beijing Municipality, +86-010
Xiao Li, M.D, +86-10-88326652, dr.lixiao@163.com
Hao Li, M.D, +86-10-88326650 ext. Li, lihao_pkuhsc@163.com
About this study
This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.
Read the detailed description
Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.
Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.
This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.
- Conditions
- Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms
- Keywords
- Non-small-cell Lung Cancer, circulating tumor DNA, urine
- 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.
The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.
Measured: 12 months
Secondary outcomes (4)
The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.
Measured: 18 months
Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.
Measured: 18 months
Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.
Measured: 3 years
Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 45 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
- Xiao Li, M.D, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907606
- Sponsor's protocol ID
- PKUPH-XW1401
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We will not make individual participant data (IPD) available
Publications
Reckamp KL, Melnikova VO, Karlovich C, Sequist LV, Camidge DR, Wakelee H, Perol M, Oxnard GR, Kosco K, Croucher P, Samuelsz E, Vibat CR, Guerrero S, Geis J, Berz D, Mann E, Matheny S, Rolfe L, Raponi M, Erlander MG, Gadgeel S. A Highly Sensitive and Quantitative Test Platform for Detection of NSCLC EGFR Mutations in Urine and Plasma. J Thorac Oncol. 2016 Oct;11(10):1690-700. doi: 10.1016/j.jtho.2016.05.035. Epub 2016 Jul 25.
PubMed 27468937Su YH, Wang M, Brenner DE, Norton PA, Block TM. Detection of mutated K-ras DNA in urine, plasma, and serum of patients with colorectal carcinoma or adenomatous polyps. Ann N Y Acad Sci. 2008 Aug;1137:197-206. doi: 10.1196/annals.1448.027.
PubMed 18837947Lin SY, Dhillon V, Jain S, Chang TT, Hu CT, Lin YJ, Chen SH, Chang KC, Song W, Yu L, Block TM, Su YH. A locked nucleic acid clamp-mediated PCR assay for detection of a p53 codon 249 hotspot mutation in urine. J Mol Diagn. 2011 Sep;13(5):474-84. doi: 10.1016/j.jmoldx.2011.05.005. Epub 2011 Jul 2.
PubMed 21726666Janku F, Vibat CR, Kosco K, Holley VR, Cabrilo G, Meric-Bernstam F, Stepanek VM, Lin PP, Leppin L, Hassaine L, Poole JC, Kurzrock R, Erlander MG. BRAF V600E mutations in urine and plasma cell-free DNA from patients with Erdheim-Chester disease. Oncotarget. 2014 Jun 15;5(11):3607-10. doi: 10.18632/oncotarget.1964.
PubMed 25003820Hyman DM, Diamond EL, Vibat CR, Hassaine L, Poole JC, Patel M, Holley VR, Cabrilo G, Lu TT, Arcila ME, Chung YR, Rampal R, Lacouture ME, Rosen N, Meric-Bernstam F, Baselga J, Kurzrock R, Erlander MG, Janku F, Abdel-Wahab O. Prospective blinded study of BRAFV600E mutation detection in cell-free DNA of patients with systemic histiocytic disorders. Cancer Discov. 2015 Jan;5(1):64-71. doi: 10.1158/2159-8290.CD-14-0742. Epub 2014 Oct 16.
PubMed 25324352Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.
PubMed 23836314
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
- ClinicalTrials.gov ID
- NCT02907606
- Acronym / sponsor ID
- PKUPH-XW1401
- Conditions
- Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms
- Keywords
- Non-small-cell Lung Cancer, circulating tumor DNA, urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- San Valley Biotechnology Incorporated
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 20 Sep 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.
This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.
Detailed description
Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.
Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.
This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.
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 non-small cell lung cancer patients with paired tumor tissue, peripheral blood samples, and urinary samples.
Key inclusion criteria (5 listed)
- Aged 18 to 80 years
- Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
- Completed and explicit information about TNM staging
- Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
- Patients must have given written informed consent
Key exclusion criteria (4 listed)
- Unable to comply with the study procedure
- Malignant tumor history within the past 5 years
- Coexisting small cell lung cancer
- Unqualified tissue, blood or urine 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
The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.
Time frame: 12 months
4 secondary outcomes
The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.
Time frame: 18 months
Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.
Time frame: 18 months
Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.
Time frame: 3 years
Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Background: PubMed 27468937Reckamp KL, Melnikova VO, Karlovich C, Sequist LV, Camidge DR, Wakelee H, Perol M, Oxnard GR, Kosco K, Croucher P, Samuelsz E, Vibat CR, Guerrero S, Geis J, Berz D, Mann E, Matheny S, Rolfe L, Raponi M, Erlander MG, Gadgeel S. A Highly Sensitive and Quantitative Test Platform for Detection of NSCLC EGFR Mutations in Urine and Plasma. J Thorac Oncol. 2016 Oct;11(10):1690-700. doi: 10.1016/j.jtho.2016.05.035. Epub 2016 Jul 25.
- Background: PubMed 18837947Su YH, Wang M, Brenner DE, Norton PA, Block TM. Detection of mutated K-ras DNA in urine, plasma, and serum of patients with colorectal carcinoma or adenomatous polyps. Ann N Y Acad Sci. 2008 Aug;1137:197-206. doi: 10.1196/annals.1448.027.
- Background: PubMed 21726666Lin SY, Dhillon V, Jain S, Chang TT, Hu CT, Lin YJ, Chen SH, Chang KC, Song W, Yu L, Block TM, Su YH. A locked nucleic acid clamp-mediated PCR assay for detection of a p53 codon 249 hotspot mutation in urine. J Mol Diagn. 2011 Sep;13(5):474-84. doi: 10.1016/j.jmoldx.2011.05.005. Epub 2011 Jul 2.
- Background: PubMed 25003820Janku F, Vibat CR, Kosco K, Holley VR, Cabrilo G, Meric-Bernstam F, Stepanek VM, Lin PP, Leppin L, Hassaine L, Poole JC, Kurzrock R, Erlander MG. BRAF V600E mutations in urine and plasma cell-free DNA from patients with Erdheim-Chester disease. Oncotarget. 2014 Jun 15;5(11):3607-10. doi: 10.18632/oncotarget.1964.
- Background: PubMed 25324352Hyman DM, Diamond EL, Vibat CR, Hassaine L, Poole JC, Patel M, Holley VR, Cabrilo G, Lu TT, Arcila ME, Chung YR, Rampal R, Lacouture ME, Rosen N, Meric-Bernstam F, Baselga J, Kurzrock R, Erlander MG, Janku F, Abdel-Wahab O. Prospective blinded study of BRAFV600E mutation detection in cell-free DNA of patients with systemic histiocytic disorders. Cancer Discov. 2015 Jan;5(1):64-71. doi: 10.1158/2159-8290.CD-14-0742. Epub 2014 Oct 16.
- Background: PubMed 23836314Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.
- Individual participant dataSharing planned: No. We will not make individual participant data (IPD) available
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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.
Xiao Li, M.D study director
Peking University 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 Carcinoma and Non-small-cell Lung Cancer, run by Peking University People's Hospital 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 5 inclusion and 4 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 20 Sep 2016. 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 Xiao Li, M.D (86-10-88326652, dr.lixiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA. (time frame: 12 months). 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 NCT02907606, which also lists 6 linked publications.
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 20 Sep 2016.