Developing a blood test for early cancer detection
PROFOUND Study: Development and Validation of a Multi-cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning: a Multicenter, Prospective, Observational, Case-control Study
This study is testing a new blood test to see if it can help find different types of cancer early by looking at blood samples from both cancer patients and healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16666 (estimated) |
| Ages | 40 Years to 74 Years |
| Sex | All |
| Sponsor | Shanghai Weihe Medical Laboratory Co., Ltd. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06217900 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a machine learning-based model for early detection of multiple cancers by collecting blood samples from newly diagnosed cancer patients and healthy individuals. The study will utilize integrative multi-omic analysis to identify cancer-specific circulating signals. Approximately 10,327 cancer patients and 6,339 age and sex-matched controls will be enrolled to enhance the model's sensitivity in distinguishing early-stage cancers. The model will undergo blinded validation to ensure its effectiveness in clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40-74 who have been clinically or pathologically diagnosed with cancer and have not received any prior cancer treatment.
Not a fit: Patients who are pregnant, have multiple malignancies, or have severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a reliable blood test for the early detection of multiple cancers, potentially improving patient outcomes through earlier intervention.
How similar studies have performed: Other studies have shown promise in using machine learning and blood-based biomarkers for cancer detection, suggesting a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Cancer Hospital and Institute — Beijing, Beijing Municipality, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Jun Wang — Peking University People's Hospital
- Study coordinator: Yong Qin
- Email: qinyong@bytedance.com
- Phone: +86 186 2629 2273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.