Performance of Multi-Cancer Detection Test in Asymptomatic Patients With Neoplastic Lesions
Performance Validation of a Blood-Based Multi-Cancer Early Detection Model in Asymptomatic Patients With Cancer and Precancerous Lesions: A Multicenter Case-Only Study
This multicenter, observational case-only study will evaluate the clinical performance of a blood-based, cell-free DNA (cfDNA) methylation multi-cancer early detection (MCED) test in adults aged 50 to 74 years with confirmed invasive cancer or selected high-risk precancerous lesions/carcinoma in situ.
The study will primarily recruit patients who had no cancer-related symptoms before diagnosis. An additional tissue-of-origin (TOO) model optimization cohort will include patients with urothelial cancer, colorectal advanced adenoma, gastric high-grade dysplasia, or esophageal high-grade dysplasia, irrespective of symptom status.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Previous case-control studies have shown promising performance in patients with established cancer diagnoses. However, conventional case-control studies predominantly enroll symptomatic patients, whose tumor burden and circulating tumor DNA (ctDNA) levels may differ from those of asymptomatic patients, even at the same cancer stage. Consequently, the sensitivity and tissue-of-origin (TOO) accuracy observed in conventional case-control studies may not fully reflect test performance in the intended screening setting. Further evaluation in asymptomatic patients with cancer is therefore needed to better characterize the technical performance of MCED tests.
This multicenter, observational, case-only study aims to evaluate the performance of a cfDNA methylation-based MCED model in patients with asymptomatic cancers and selected high-risk precancerous lesions or carcinoma in situ. The study will also support targeted optimization of the TOO prediction model for selected disease categories.
Approximately 948 participants are planned for consent and pre-treatment blood sampling. MCED test results will not be disclosed to participants or treating investigators or used to guide clinical management. The study is expected to provide additional evidence on the technical performance of cfDNA methylation-based MCED testing in asymptomatic patients and to support further model development and clinical evaluation.
Studietype
Inschrijving (Geschat)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients from hospitals: inpatient and outpatient
Beschrijving
Asymptomatic Cohort
Inclusion Criteria:
- Clinically and/or pathologically diagnosed with any one of the 13 invasive cancers including lung cancer, gastric cancer, etc., or diagnosed with high-risk precancerous lesions / carcinoma in situ corresponding to these 13 cancers.
- 50-74 years old.
- Self-reported absence of prespecified symptoms related to the corresponding cancer prior to diagnosis.
- 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:
- Female subjects with self-reported pregnancy.
- Severe infection within 14 days before screening.
- Recipients of blood transfusion within 7 days prior to screen
- With active autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc.
- Other conditions judged by the investigator to render the subject ineligible for participation in this study.
TOO Model Optimization Cohort:
Inclusion Criteria:
- Clinically and/or pathologically diagnosed with any of the following diseases: urothelial carcinoma of the bladder, advanced colorectal adenomas, high-grade gastric intraepithelial neoplasia, or high-grade esophageal intraepithelial neoplasia
- 50-74 years old.
- 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:
- Female subjects with self-reported pregnancy.
- Severe infection within 14 days before screening.
- Recipients of blood transfusion within 7 days prior to screen
- With active autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc.
- Other conditions judged by the investigator to render the subject ineligible for participation in this study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_ONLY
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Asymptomatic Cohort
|
A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay. |
|
TOO Model Optimization Cohort
|
A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sensitivity of Cancer Signal Detection (CSD)
Tijdsspanne: 6 months after the completion of enrollment
|
The proportion of participants with a positive CSD result among those with clinically and/or pathologically confirmed eligible diseases, calculated overall and by disease category, with corresponding 95% confidence intervals. |
6 months after the completion of enrollment
|
|
Accuracy of Tissue-of-Origin (TOO) Prediction
Tijdsspanne: 6 months after the completion of enrollment
|
The proportion of CSD-positive participants whose predicted TOO category matches the clinically and/or pathologically confirmed disease site, calculated overall and by disease category, with corresponding 95% confidence intervals. |
6 months after the completion of enrollment
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Genie-Priori-I
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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