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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04903665
• Other study ID #: FDZL-2021002
• Status: Active, not recruiting
• Start date: February 11, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 495
• Est. completion date: December 31, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Device:
• Multi-cancer early detection test
Blood collection and multi-cancer early detection testing

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Guangzhou Burning Rock Bioengineering Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.		12 months
Secondary	Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages.		12 months
Secondary	Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases		12 months