Multi-cancer early detection using blood samples and machine learning
INSPIRE: Integrating Circulating DNA Methylation and Fragmentomics to Scan and Pinpoint Cancer Signals Effectively
This study is testing a new way to detect multiple types of cancer early by looking at blood samples and using machine learning to find specific patterns in DNA.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5350 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Singlera Genomics Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shnaghai) |
| Trial ID | NCT06440018 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a machine learning model for early detection of multiple cancers by analyzing blood samples from newly diagnosed cancer patients and healthy individuals. The research will focus on identifying specific methylation patterns in cell-free DNA (cfDNA) to create a comprehensive methylation signature panel tailored for cancer detection. Approximately 2,650 cancer patients and 2,400 control subjects will be enrolled, with an emphasis on early-stage cancer cases to improve detection sensitivity. The study will also include samples from additional patients with other tumors to ensure the robustness of the model's performance.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40-75 who have been clinically or pathologically diagnosed with cancer and have not received any prior antitumor therapy.
Not a fit: Patients who are pregnant, lactating, or have a history of other malignancies or recent interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of multiple types of cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies utilizing machine learning for cancer detection have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Case Arm Participants: * 40-75 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 * Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug; * 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 * Failure to collect blood on time according to plan * The blood sample does not meet the requirements Inclusion Criteria for Control Arm Participants: * 40-75 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 * No previous history of malignancy in other sites * 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
Shanghai, Shnaghai
- Fudan University — Shanghai, Shnaghai, China (Recruiting)
Study contacts
- Study coordinator: Zhixi Su, PHD
- Email: zhixi.su@singlera.com
- Phone: +862180113170
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.