The Unintrusive Detection of EaRly-stage Cancers

NCT ID: NCT04820868

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2508 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2022-04-30

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.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer Arm

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

Multi-cancer early detection test

Intervention Type: DEVICE

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

Multi-cancer early detection test

Intervention Type: DEVICE

Blood collection and multi-cancer early detection test

Interventions

Multi-cancer early detection test

Blood collection and multi-cancer early detection test

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ability to provide a written informed consent
• 40-75 years old
• Ability to comply with study procedures

• 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

• 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

• 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

• 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

• Prior or ongoing treatment of cancer within 3 years prior to study blood draw
• Clinically significant or uncontrolled comorbidities

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Gao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

RSCD2020003

Identifier Type: -

Identifier Source: org_study_id