Lung CancerNCT04817046
Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG)
An observational study of Lung Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Lung Cancer
- How many people
- 467 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2021to 31 Dec 2024
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed lung cancer patients between 40-75 years old, with solid nodule on CT imaging.
Who may be able to join
- Signed informed consent
- Male or female, age equal to or greater than 40 years old and less than 75 years old
- Blood sample was collected before surgery for the detection of cfDNA methylation and other biomarkers
- Lung cancer patients diagnosed for the first time within 42 days before blood sampling without any anti-tumor treatment; or patients who are highly suspected of lung cancer through imaging evaluation or other routine clinical diagnosis and confirmed by tissue biopsy or surgical specimens within 42 days after blood sampling
- The subject has not received any local or systemic anti-tumor therapy before blood collection, including (not limited to) any surgery, local or systemic radiotherapy and chemotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines and hormone therapy, etc.
Who cannot join
- Unable to obtain sufficient and qualified blood samples
- Female subjects who are pregnant or breastfeeding
- Patients who have received organ transplantation or non-autologous bone marrow or stem cell transplantation
- Patients who have received blood transfusion within 7 days before blood sampling
- Patients who have received anti-infection treatment within 14 days before blood collection
- Patients who have receiving anti-tumor drugs for other diseases within 30 days before blood collection, such as methotrexate, cyclophosphamide, mercaptopurine, chlorambucil, tamoxifen, etc.
Show all 10Show fewer
- Patients who suffered from other malignant tumors or multiple primary tumors at the same time
- Pathological confirmed benign lesions by tissue biopsy or surgery
- Insufficient sample for a confirmed pathological diagnosis
- Lung cancer patients with ground glass nodules on CT imaging.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Chen Kezhong, M.D.
About this study
Official title: Detection of Early-stage Lung Cancer Based on Liquid Biopsy of Peripheral Blood: a Prospective Study
The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening process to determine eligibility of study entry. Peripheral blood, tissue sample and imaging examinations of eligible patients will be collected for further analysis. Data collected will be used to develop a multi-omics lung cancer diagnosis model.
- Conditions
- Lung Cancer
- Keywords
- Liquid Biopsy
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the multi-omics early-stage lung cancer diagnosis model
Sensitivity and specificity of the multi-omics early-stage lung cancer diagnosis model
Measured: through study completion, an average of 1.5 year
Secondary outcomes (2)
Accuracy of diagnostic models established separately from multi-omics data
Sensitivity and specificity models established separately from multi-omics data
Measured: through study completion, an average of 1.5 year
Relationship between multi-omics data
Explore the relationship of features extracted from multi-omics data
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start19 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (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 CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 467 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Fan Yang, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817046
- Sponsor's protocol ID
- PTHO2101
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin Y, Mu W, Shi Y, Qi Q, Wang W, He Y, Sun X, Yang B, Cui P, Li C, Liu F, Liu Y, Wang G, Zhao J, Zhang Y, Zhang S, Cao C, Sun C, Hong N, Cai S, Tian J, Yang F, Chen K. Development and validation of an integrated system for lung cancer screening and post-screening pulmonary nodules management: a proof-of-concept study (ASCEND-LUNG). EClinicalMedicine. 2024 Aug 3;75:102769. doi: 10.1016/j.eclinm.2024.102769. eCollection 2024 Sep.
PubMed 39165498
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early-stage Lung Cancer Based on Liquid Biopsy of Peripheral Blood: a Prospective Study
- ClinicalTrials.gov ID
- NCT04817046
- Acronym / sponsor ID
- PTHO2101
- Conditions
- Lung Cancer
- Keywords
- Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 467 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Mar 2021 (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.
The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening process to determine eligibility of study entry. Peripheral blood, tissue sample and imaging examinations of eligible patients will be collected for further analysis. Data collected will be used to develop a multi-omics lung cancer diagnosis model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed lung cancer patients between 40-75 years old, with solid nodule on CT imaging.
Key inclusion criteria (5 listed)
- Signed informed consent
- Male or female, age equal to or greater than 40 years old and less than 75 years old
- Blood sample was collected before surgery for the detection of cfDNA methylation and other biomarkers
- Lung cancer patients diagnosed for the first time within 42 days before blood sampling without any anti-tumor treatment; or patients who are highly suspected of lung cancer through imaging evaluation or other routine clinical diagnosis and confirmed by tissue biopsy or surgical specimens within 42 days after blood sampling
- The subject has not received any local or systemic anti-tumor therapy before blood collection, including (not limited to) any surgery, local or systemic radiotherapy and chemotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines and hormone therapy, etc.
Key exclusion criteria (10 listed)
- Unable to obtain sufficient and qualified blood samples
- Female subjects who are pregnant or breastfeeding
- Patients who have received organ transplantation or non-autologous bone marrow or stem cell transplantation
- Patients who have received blood transfusion within 7 days before blood sampling
- Patients who have received anti-infection treatment within 14 days before blood collection
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
Accuracy of the multi-omics early-stage lung cancer diagnosis model
Time frame: through study completion, an average of 1.5 year
Sensitivity and specificity of the multi-omics early-stage lung cancer diagnosis model
2 secondary outcomes
Accuracy of diagnostic models established separately from multi-omics data
Time frame: through study completion, an average of 1.5 year
Relationship between multi-omics data
Time frame: through study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 39165498Jin Y, Mu W, Shi Y, Qi Q, Wang W, He Y, Sun X, Yang B, Cui P, Li C, Liu F, Liu Y, Wang G, Zhao J, Zhang Y, Zhang S, Cao C, Sun C, Hong N, Cai S, Tian J, Yang F, Chen K. Development and validation of an integrated system for lung cancer screening and post-screening pulmonary nodules management: a proof-of-concept study (ASCEND-LUNG). EClinicalMedicine. 2024 Aug 3;75:102769. doi: 10.1016/j.eclinm.2024.102769. eCollection 2024 Sep.
- 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.
Fan Yang, MD study chair
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 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 10 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 25 Mar 2021. 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 Kezhong Chen, MD (08601088326650, chenkezhong@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the multi-omics early-stage lung cancer diagnosis model (time frame: through study completion, an average of 1.5 year). 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 NCT04817046, 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 25 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.