Pan-canceR Early DetectIon projeCT

Study Overview
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Brief Summary
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PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.

Official Title
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Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Cancer Arm Participants: Able to provide a written informed consent. Able to provide sufficient and qualified blood samples for study tests. No prior or undergoing cancer treatment (local or systematic) with either of the following: A. Pathologically confirmed cancer diagnosis within 30 (±7) days prior to the study blood draw. B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 36 (±7) days after study blood draw. Exclusion Criteria for Cancer Arm Participants: Insufficient qualified blood sample for study test. During pregnancy or lactation. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. Recipient of blood transfusion within 30 days prior to study blood draw. With other known malignant tumors or multiple primary tumors. Inclusion Criteria for Benign Disease Arm Participants: Able to provide a written informed consent. Able to provide sufficient and qualified blood samples for study tests. Have either of the following: A. Pathological confirmed diagnosis of benign diseases within 90 (±7) days prior to the study blood draw, with no prior treatment such as surgical resection. B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 36 (±7) days after study blood draw. Exclusion Criteria for Benign Disease Arm Participants: Insufficient qualified blood sample for study test. During pregnancy or lactation. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. Recipient of blood transfusion within 30 days prior to study blood draw. Inclusion Criteria for Non-Tumor Arm Participants: Able to provide a written informed consent. Able to provide sufficient and qualified blood samples for study tests. No cancer related symptoms within 30 days prior to study screening. Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment. Exclusion Criteria for Non-Tumor Arm Participants: Insufficient qualified blood sample for study test. During pregnancy or lactation. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. Recipient of blood transfusion within 30 days prior to study blood draw. Recipient of anti-infectious therapy within 14 days prior to study blood draw. Have received or are undergoing curative cancer treatment within three years prior to study screening. With autoimmune or other diseases with severe comorbidities.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer arm<br>Participants with new diagnosis of cancer, from whom a blood sample and contemporaneous tissue samples will be collected. | |
| Benign disease arm<br>Participants with benign diseases corresponding to the tumor types in the cancer arm, from whom a blood sample and contemporaneous tissue samples will be collected. | |
| Non-tumor arm (Healthy)<br>Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens. |  | 32 months | 
| The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model. |  | 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups. |  | 32 months | 
| The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers. |  | 32 months | 
| The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations. |  | 32 months | 
| The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets. |  | 32 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, cell-free DNA (cfDNA) methylation, early detection