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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04903665

Enrollment

495

Registered

2021-05-26

Start date

2021-02-11

Completion date

2022-12-31

Last updated

2022-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer

Keywords

gynecologic cancer, early detection, liquid biopsy, cell-free DNA

Brief summary

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.

Interventions

DEVICEMulti-cancer early detection test

Blood collection and multi-cancer early detection testing

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026