Cancer Clinical Trial
— THUNDEROfficial title:
A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection
NCT number | NCT04820868 |
Other study ID # | RSCD2020003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 23, 2021 |
Est. completion date | April 30, 2022 |
Verified date | March 2023 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2508 |
Est. completion date | April 30, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria for All the Participants: - Ability to provide a written informed consent - 40-75 years old - Ability to comply with study procedures Exclusion Criteria for All the Participants: - Pregnancy or lactating women - Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant - Recipients of blood transfusion within 7 days prior to study blood draw - 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: - Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw. - No prior anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: - Known prior or current diagnosis of other types of malignancies or multiple primary tumors - Diagnosis of benign diseases by histopathological assessments - 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 - Non-small-cell lung cancer patients with ground-class nodularity by radiological examination - Diagnosis of precancerous lesions Inclusion Criteria for Healthy Arm Participants: - No cancer-related symptoms or discomfort within 30 days prior to study blood draw - No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound - No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants - No active hepatitis B or hepatitis C infection Exclusion Criteria for Healthy Arm Participants: - Prior or ongoing treatment of cancer within 3 years prior to study blood draw - Clinically significant or uncontrolled comorbidities |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | Guangzhou Burning Rock Dx Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer | 7 months |
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