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A clinical study of liquid biopsy-based cfDNA fragmentomics-assisted early lung cancer screening

A clinical study of liquid biopsy-based cfDNA fragmentomics-assisted early lung cancer screening

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081920
Enrollment
Unknown
Registered
2024-03-15
Start date
2023-08-12
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early stage lung cancer

Interventions

invasive lung cancer (stage I):None
non-invasive lung cancer (including benign lung nodules and carcinoma in situ) confirmed by pathology:None

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Age greater than 18 years old, male or female; 2)Patients with benign nodules, carcinoma in situ and stage I lung cancer diagnosed by histologic and/or cytologic examination; 3)Patients with single nodule in the lung; 4)The ability to obtain comprehensive clinical and pathologic information about them; 5) Subjects read and fully understood the patient instructions and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1)Patients with multiple nodules in the lungs; 2)Female population during pregnancy; 3)Current diagnosis of tumors other than lung cancer or previous history of tumors; 4)Received any form of oncologic therapy, including surgery, radiation/chemotherapy, targeted therapy, and immunotherapy prior to enrollment in the blood draw; 5) Those with a current febrile illness or who have had an acute exacerbation or flare-up of an inflammatory disease within 14 days prior to the blood draw that requires them to be under medical treatment; 6)Organ transplant recipients or people with prior non-autologous (allogeneic) bone marrow or stem cell transplantation; 7)People who are in poor health or unfit to have their blood drawn; 8) any other disease or condition of clinical significance that, in the opinion of the investigator, could affect adherence to the protocol, or affect the patient's ability to sign the informed consent form, or make participation in this clinical trial inappropriate.

Design outcomes

Primary

MeasureTime frame
Subject copy number changes;cfDNA fragment length;cfDNA fragment end motif;cfDNA fragment breakpoint motif;

Countries

China

Contacts

Public ContactHu Bin

Beijing Chao-Yang Hospital, Capital Medical University

hubin705@aliyun.com+86 139 0130 0750

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026