The Unintrusive Detection of EaRly-stage Cancers

NCT04820868 | Completed DMC

• 1 other identifier: RSCD2020003
• Study Type: observational
• Target: 2,508
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer; Liquid biopsy; Cell-free DNA (cfDNA); Early detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer

  7 months

Study Arms (2)

Cancer Arm

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

Device: 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

Interventions

Multi-cancer early detection test DEVICE

Blood collection and multi-cancer early detection test

Cancer Arm; Healthy Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of malignancies and healthy participants.

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Qiang Gao, M.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: April 23, 2021
• Primary Completion: November 30, 2021
• Study Completion: April 30, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)