PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I

Study Overview
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Brief Summary
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This study is a prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 495 female participants, including participants with gynecologic cancers or benign diseases.

Official Title
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Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Device: Multi-cancer early detection test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Cancer Arm Participants: Age 18 years or older Able to provide a written informed consent Confirmed diagnosis or highly suspicious cases of gynecologic malignancies No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: Pregnancy or lactating women Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant Recipients of blood transfusion within 7 days prior to study blood draw Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer Inclusion Criteria for Benign Arm Participants: Age 18 years or older Able to provide a written informed consent Confirmed diagnosis of benign gynecologic diseases No prior radical treatment of the benign diseases prior to study blood draw Exclusion Criteria for Benign Arm Participants: Pregnancy or lactating women Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant Recipients of blood transfusion within 7 days prior to study blood draw Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 gynecologic cancers, from whom blood samples will be collected. | Device: Multi-cancer early detection test<br>* Blood collection and multi-cancer early detection testing<br>|
| Benign Arm<br>Participants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected. | Device: Multi-cancer early detection test<br>* Blood collection and multi-cancer early detection testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages. |  | 12 months | 
| Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynecologic cancer, early detection, liquid biopsy, cell-free DNA