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Status unknownNCT04817046Updated Mar 25, 2021

Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG)

An observational study in Lung Cancer, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-03-25.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
467
Ages
40 Years to 74 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Lung Cancer

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Keywords

  • Liquid Biopsy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 467 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed lung cancer patients between 40-75 years old, with solid nodule on CT imaging.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
467 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Accuracy of the multi-omics early-stage lung cancer diagnosis model

    Sensitivity and specificity of the multi-omics early-stage lung cancer diagnosis model

    Time frame: through study completion, an average of 1.5 year

Secondary outcomes

  1. Accuracy of diagnostic models established separately from multi-omics data

    Sensitivity and specificity models established separately from multi-omics data

    Time frame: through study completion, an average of 1.5 year

  2. Relationship between multi-omics data

    Explore the relationship of features extracted from multi-omics data

    Time frame: through study completion, an average of 1.5 year

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Study locations

1 of 1 sites recruiting
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
    • Chen Kezhong, M.D. · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04817046
Lead sponsor
Peking University People's Hospital
Responsible party
Jun Wang (Professor, Peking University People's Hospital) — Principal investigator
First posted
Mar 25, 2021
Start date
Feb 19, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 25, 2021

Study contacts

Kezhong Chen, MD
Contact
chenkezhong@pkuph.edu.cn
08601088326650
Fan Yang, MD
Contact
yangfan@pkuph.edu.cn
08601088326650
Fan Yang, MD
study chair · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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