a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Det… (NCT06217900) | Clinical Trial Compass
RecruitingNot Applicable
a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection(PROFOUND)
China16,666 participantsStarted 2023-12-28
Plain-language 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.
Who can participate
Age range40 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 malignancie…
What they're measuring
1
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study
Timeframe: 12 months
Trial details
NCT IDNCT06217900
SponsorShanghai Weihe Medical Laboratory Co., Ltd.