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NCT Number: NCT04820868

The Unintrusive Detection of EaRly-stage Cancers

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.

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Key information

Conditions

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Cancer Early Detection Test

Device

Blood collection and multi-cancer early detection test

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

    Time frame: 7 months

Secondary outcomes

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

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Guangzhou Burning Rock Dx Co., Ltd.

Registry information

Official study title

A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection

Acronym: THUNDER

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 29, 2021
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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