THUNDER: The Unintrusive Detection of EaRly-stage Cancers
Study Details
Study Description
Brief Summary
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer Arm Participants with new diagnosis of cancer, from whom blood samples will be collected |
Device: Multi-cancer early detection test
Blood collection and multi-cancer early detection test
|
| Healthy Arm Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected |
Device: Multi-cancer early detection test
Blood collection and multi-cancer early detection test
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model [7 months]
Secondary Outcome Measures
- Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer [7 months]
Eligibility Criteria
Criteria
Inclusion Criteria for All the Participants:
-
Ability to provide a written informed consent
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40-75 years old
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Ability to comply with study procedures
Exclusion Criteria for All the Participants:
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Pregnancy or lactating women
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Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
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Recipients of blood transfusion within 7 days prior to study blood draw
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Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
Inclusion Criteria for Cancer Arm Participants:
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Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
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No prior anti-cancer therapy (local or systematic) prior to study blood draw
Exclusion Criteria for Cancer Arm Participants:
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Known prior or current diagnosis of other types of malignancies or multiple primary tumors
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Diagnosis of benign diseases by histopathological assessments
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No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
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Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
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Diagnosis of precancerous lesions
Inclusion Criteria for Healthy Arm Participants:
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No cancer-related symptoms or discomfort within 30 days prior to study blood draw
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No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound
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No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
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No active hepatitis B or hepatitis C infection
Exclusion Criteria for Healthy Arm Participants:
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Prior or ongoing treatment of cancer within 3 years prior to study blood draw
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Clinically significant or uncontrolled comorbidities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital, Fudan University | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
- Guangzhou Burning Rock Dx Co., Ltd.
Investigators
- Principal Investigator: Qiang Gao, M.D., Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- RSCD2020003