Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5350 participants
OBSERVATIONAL
2024-07-20
2025-02-28
Brief Summary
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Detailed Description
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We will prospectively collect blood samples from newly diagnosed cancer patients and non-cancer individuals to analyze and identify specific cancer signals via the detection of cfDNA methylation patterns. Following a rigorous and comprehensive research framework, a machine learning-driven model will be developed and validated through blinded testing in an independent cohort. The study aims to enroll approximately 2,650 cancer patients, with a focus on including early-stage cases to enhance the model's sensitivity in detecting cancers with favorable prognoses. Furthermore, around 2,400 control subjects, matched with cancer patients by age and gender and screened negative for cancer through routine tests, will participate as healthy or benign-condition volunteers in model development. Lastly, samples from an additional 300 patients with other tumors will be gathered to conduct interference testing, ensuring the robustness of the model's performance.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case arm
Participants newly diagnosed with cancer, belonging to one of thirteen distinct cancer types.
No interventions assigned to this group
Control arm
Healthy or benign condition participants with no cancer diagnosis subsequent to routine cancer screening tests.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinically and/or pathologically diagnosed cancer
* No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures
* 40-75 years old
* Without confirmed cancer diagnosis
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Exclusion Criteria
* Known prior or current diagnosis of other types of malignancies comorbidities
* Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to screen
* Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Failure to collect blood on time according to plan
* The blood sample does not meet the requirements
* Pregnancy or lactating women
* No previous history of malignancy in other sites
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to screen
* Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers
40 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Hubei Cancer Hospital, Huazhong University of Science and Technology
UNKNOWN
China-Japan Friendship Hospital
OTHER
Shaanxi Provincial Cancer Hospital
OTHER
Xuhui Central Hospital, Fudan University
UNKNOWN
Shanghai Electric Power Hospital
UNKNOWN
East Hospital, Tongji University
UNKNOWN
The First Affiliated Hospital of Xi' an Jiaotong University
UNKNOWN
GaoZhou People's Hosipital
UNKNOWN
Anhui Provincial Hospital
OTHER_GOV
Beijing Friendship Hospital
OTHER
Singlera Genomics Inc.
INDUSTRY
Responsible Party
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Locations
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Fudan University
Shanghai, Shnaghai, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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multiple
Identifier Type: -
Identifier Source: org_study_id
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