Status:
RECRUITING
a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）
Lead Sponsor:
Shanghai Weihe Medical Laboratory Co., Ltd.
Collaborating Sponsors:
Peking University People's Hospital
Conditions:
Cancer
Eligibility:
All Genders
40-74 years
Brief 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 n...
Detailed Description
Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrativ...
Eligibility Criteria
Inclusion
- 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.) or febrile illness (body temperature of ≥ 38.5 °C) 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 antibiotics, 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.) or febrile illness (body temperature of ≥ 38.5 °C) 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 antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
- Unsuitable for this trial determined by the researchers
Exclusion
Key Trial Info
Start Date :
December 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
16666 Patients enrolled
Trial Details
Trial ID
NCT06217900
Start Date
December 28 2023
End Date
March 31 2027
Last Update
January 23 2024
Active Locations (2)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, China, 100083