Clinical trial NCT04820868: The Unintrusive Detection of EaRly-stage Cancers
Official title: A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Liquid biopsy
Cell-free DNA (cfDNA)
Early detection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Dx Co., Ltd.
First posted: 2021-03-29
Enrollment: 2508
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model
timeFrame: 7 months
Secondary outcomes:
measure: Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer
timeFrame: 7 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Qiang Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: