CarcinomaNCT03664843
Circulating Tumor DNA Longitudinal Monitoring in Stage III-IV Lung Cancer Patients
An observational study of Carcinoma and Non-small Cell Lung Cancer, run by First Hospital of Shijiazhuang City at 8 sites in China.
Trial summary
Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV 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 Neoplasm
- How many people
- 120 participants
- Where
- 8 sitesChina
- Study dates
- 9 Nov 2018to 1 Sep 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: The population will be drawn from Oncology Department of multicenters. The enrolled patients must be patients with stage III-IV NSCLC according to the 8th edition of the TNM Classification of the International Association for the Study of Lung Cancer (IASLC), must be greater than 18 years old and must have the tissue specimens (fresh or wax blocks) before this treatment. The exclusion criteria are as followed: (1) Multiple primary lung cancer;(2) Incorporating any unstable systemic disease; (3) Histology is not NSCLC; (4)Unqualified blood samples; (5) Patients lacking any one of the detection points. All of the patients signing informed consent were not involved in the recruitment and conduct of the study
Who may be able to join
- Greater than 18 years old;
- Patients with stage III-IV NSCLC;
- Have the tissue specimens (fresh or wax blocks) before this treatment;
- PS<=2 in radiotherapy/ chemotherapy group; PS<=3 in targeted therapy group
- Signing informed consent;
Who cannot join
- Multiple primary lung cancer;
- Incorporating any unstable systemic disease;
- Histology is not NSCLC;
- Unqualified blood samples;
- Patients lacking any one of the detection points.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Yanhong Shang, 13930811186 ext. +86
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Kezhong Chen, M.D., 13488752289 ext. +86, mdkzchen@163.com
- Recruiting
Handan Downtown Hospital
Handan, Heibe, 056001
Yuquan Ma
- Recruiting
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050011
Wenbin Shen
- Recruiting
The First Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050011
Yan Zhang, M.D., 17603119607 ext. +86, 13315978836@163.com
Zhenlin Gao, 18803216093 ext. +86, gaozhenlin87@126.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Dingzhi Huang, M.D., 13116047308 ext. +86
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Jun Chen, M.D., 15822192921 ext. +86
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054031
Xiaozhen Wang
About this study
Official title: A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.
Read the detailed description
The study consists of two phases, the first stage is the exploratory stage of blood collection point which is the appropriate effective time after chemotherapy, radiotherapy, targeted therapy. The second phase, which is the expansion of the first phase, is to determine the precise leading time of ctDNA relative to tumor biomarkers or image evaluation in determining the efficacy of advanced NSCLC cancer therapy. Both stages were divided into three subgroups: the chemotherapy group, the radiotherapy group, and the targeted therapy group.
- Conditions
- Carcinoma, Non-small Cell Lung Cancer, Lung Neoplasm
- Keywords
- circulating tumor DNA, lung cancer, surveillance, longitudinal monitoring, lead time
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The chemotherapy cohort | Blood samples for ctDNA and biomarkers analysis are collected at before chemotherapy and at a series of scheduled time-points after chemotherapy , with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | |
| The radiotherapy cohort | Blood samples for ctDNA and biomarkers analysis are collected at before radiotherapy and at a series of scheduled time-points after radiotherapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | |
| The targeted therapy cohort | Blood samples for ctDNA and biomarkers analysis are collected at before targeted therapy and at a series of scheduled time-points after targeted therapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA effective time
To explore the appropriate chemo/ radio/ target effective time (CET/RET/TET) through measurement and monitoring of ctDNA after anti-cancer therapies in advanced NSCLC.
Measured: 6 months
ctDNA leading time
To investigate the precise leading time for ctDNA compared to conventional biomarker or image evaluation in detecting disease recurrence after radiotherapy, chemotherapy, or targeted therapy respectively.
Measured: 1 year
Secondary outcomes (3)
Assess the accuracy of ctDNA
To assess the accuracy of ctDNA when imaging undetectable or difficult to assess
Measured: 1 year
Compared to conventional image
Compared to conventional image evaluation, to determine the consistency of ctDNA in treatment response of measurable lesion after radiotherapy, chemotherapy, or targeted therapy respectively
Measured: 1 year
Compared to traditional tumor markers
To explore the consistency for ctDNA in determining the efficacy of advanced NSCLC compared to tumor markers after radiotherapy, chemotherapy, or targeted therapy respectively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start9 Nov 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 Sep 2020 (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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of Shijiazhuang City
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Tianjin Medical University General Hospital, Tianjin Medical University Cancer Institute and Hospital, Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital, Xingtai People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yan Zhang, M.D., Principal investigator, The First Hospital of ShijiazhuangJun Wang, M.D., Study chair, Peking University People's HospitalKezhong Chen, M.D., Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664843
- Sponsor's protocol ID
- PTH01801
- Status last verified
- Nov 2018
- First submitted
- 7 Sep 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT03664843
- Acronym / sponsor ID
- PTH01801
- Conditions
- Carcinoma, Non-small Cell Lung Cancer, Lung Neoplasm
- Keywords
- circulating tumor DNA, lung cancer, surveillance, longitudinal monitoring, lead time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Hospital of Shijiazhuang CityUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Tianjin Medical University General Hospital, Tianjin Medical University Cancer Institute and Hospital, Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital, Xingtai People's Hospital
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 11 Sep 2018 (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 in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.
Detailed description
The study consists of two phases, the first stage is the exploratory stage of blood collection point which is the appropriate effective time after chemotherapy, radiotherapy, targeted therapy. The second phase, which is the expansion of the first phase, is to determine the precise leading time of ctDNA relative to tumor biomarkers or image evaluation in determining the efficacy of advanced NSCLC cancer therapy. Both stages were divided into three subgroups: the chemotherapy group, the radiotherapy group, and the targeted therapy group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The chemotherapy cohort | – | –Blood samples for ctDNA and biomarkers analysis are collected at before chemotherapy and at a series of scheduled time-points after chemotherapy , with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. |
| The radiotherapy cohort | – | –Blood samples for ctDNA and biomarkers analysis are collected at before radiotherapy and at a series of scheduled time-points after radiotherapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. |
| The targeted therapy cohort | – | –Blood samples for ctDNA and biomarkers analysis are collected at before targeted therapy and at a series of scheduled time-points after targeted therapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be drawn from Oncology Department of multicenters. The enrolled patients must be patients with stage III-IV NSCLC according to the 8th edition of the TNM Classification of the International Association for the Study of Lung Cancer (IASLC), must be greater than 18 years old and must have the tissue specimens (fresh or wax blocks) before this treatment. The exclusion criteria are as followed: (1) Multiple primary lung cancer;(2) Incorporating any unstable systemic disease; (3) Histology is not NSCLC; (4)Unqualified blood samples; (5) Patients lacking any one of the detection points. All of the patients signing informed consent were not involved in the recruitment and conduct of the study
Key inclusion criteria (5 listed)
- Greater than 18 years old;
- Patients with stage III-IV NSCLC;
- Have the tissue specimens (fresh or wax blocks) before this treatment;
- PS<=2 in radiotherapy/ chemotherapy group; PS<=3 in targeted therapy group
- Signing informed consent;
Key exclusion criteria (5 listed)
- Multiple primary lung cancer;
- Incorporating any unstable systemic disease;
- Histology is not NSCLC;
- Unqualified blood samples;
- Patients lacking any one of the detection points.
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
ctDNA effective time
Time frame: 6 months
To explore the appropriate chemo/ radio/ target effective time (CET/RET/TET) through measurement and monitoring of ctDNA after anti-cancer therapies in advanced NSCLC.
ctDNA leading time
Time frame: 1 year
To investigate the precise leading time for ctDNA compared to conventional biomarker or image evaluation in detecting disease recurrence after radiotherapy, chemotherapy, or targeted therapy respectively.
3 secondary outcomes
Assess the accuracy of ctDNA
Time frame: 1 year
Compared to conventional image
Time frame: 1 year
Compared to traditional tumor markers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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.
Yan Zhang, M.D. principal investigator
The First Hospital of Shijiazhuang
Jun Wang, M.D. study chair
Peking University People's Hospital
Kezhong Chen, M.D. study director
Peking University People's Hospital
8 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 First Hospital of Shijiazhuang City at 8 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 5 inclusion and 5 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 Yan Zhang, M.D. (17603119607 ext. +86, 13315978836@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA effective time (time frame: 6 months). The study lists 2 primary outcomes in all. 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 13 Nov 2018.