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

Fudan University

Status: Active, not recruiting

Conditions: Gynecologic Cancer

Treatments: Device: Multi-cancer early detection test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04903665

FDZL-2021002

Details and patient eligibility

About

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.

Enrollment: 495 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

495 participants in 2 patient groups

Cancer Arm

Description:

Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected.

Treatment:

Device: Multi-cancer early detection test

Benign Arm

Description:

Participants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected.

Treatment:

Device: Multi-cancer early detection test