The Unintrusive Detection of EaRly-stage Cancers (THUNDER)

Fudan University

Status: Completed

Conditions: Cancer

Treatments: Device: Multi-cancer early detection test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04820868

RSCD2020003

Details and patient eligibility

About

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.

Enrollment: 2,508 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,508 participants in 2 patient groups

Cancer Arm

Description:

Participants with new diagnosis of cancer, from whom blood samples will be collected

Treatment:

Device: Multi-cancer early detection test

Healthy Arm

Description:

Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected

Treatment:

Device: Multi-cancer early detection test