Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT (PRESCIENT)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Cancer

Treatments: Device: Multi-cancer early detection test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04822792

RSCD2020002

Details and patient eligibility

About

PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, and healthy participants.

Enrollment: 11,879 estimated 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

Exclusion Criteria for All the Participants:

• Inability to comply with study procedures
• 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 one of the 22 types of malignancies within 42 days prior to study blood draw
• No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

• Known prior diagnosis of malignancies
• Other current malignant diseases or multiple primary tumors
• No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease by histopathological assessments, or inability to characterize whether the lesion is malignant or benign
• Non-small-cell lung cancer patients with ground-class nodularity by radiological examination

Inclusion Criteria for Benign Diseases Arm Participants:

• Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw
• No prior treatment of benign diseases prior to study blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

• History of malignancies
• Current malignancies or precancerous lesions
• No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign

Inclusion Criteria for Non-tumor (Healthy) Arm Participants:

• No cancer-related symptoms or discomfort within 30 days prior to study blood draw
• No clinically significant finding by 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 Non-tumor (Healthy) Arm Participants:

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

Trial design

11,879 participants in 3 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

Benign Diseases Arm

Description:

Participants with benign diseases corresponding to the tumor types in the Cancer Arm, 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 disease, from whom blood samples will be collected

Treatment:

Device: Multi-cancer early detection test