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Clinical Trials in China / NCT06217900
Recruiting Observational

a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection(PROFOUND)

NCT06217900 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Weihe Medical Laboratory Co., Ltd.
Phase
Observational
Started
2023-12-28
Last updated
2026-09-11

Condition(s) studied

Cancer

Study summary

This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.

Eligibility

Sex
ALL
Min age
40 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria for Case Arm Participants: * 40-74 years old * Clinically and/or pathologically diagnosed cancer * No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Case Arm Participants: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to screen * Recipients of therapy in past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide * Unsuitable for this trial determined by the researchers Inclusion Criteria for Control Arm Participants: * 40-74 years old * Without confirmed cancer diagnosis * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Control Arm Participants: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to screen * Recipients of therapy in the past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide * Unsuitable for this trial determined by the researchers

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting
Peking University Cancer Hospital and Institute Beijing Beijing Municipality Active Not Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences Beijing China Active Not Recruiting
The First Hospital of Jilin University Changchun China Active Not Recruiting
The First Affiliated Hospital, Sun Yat-sen University Guangzhou China Active Not Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou China Active Not Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China Active Not Recruiting
Liaoning Tumor Hospital & Institute Shenyang China Active Not Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06217900 on ClinicalTrials.gov ↗ ← All trials in China