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

NCT04903665 | Unknown

• 1 other identifier: FDZL-2021002
• Study Type: observational
• Target: 495
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.

  12 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Cancer Arm

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

Device: Multi-cancer early detection test

Benign Arm

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

Device: Multi-cancer early detection test

Interventions

Multi-cancer early detection test DEVICE

Blood collection and multi-cancer early detection testing

Benign Arm; Cancer Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of gynecologic malignancies and benign gynecologic diseases.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Fudan University: lead
• Guangzhou Burning Rock Bioengineering Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, white blood cells and formalin fixed, paraffin embedded (FFPE) tumor tissue

Study Officials

• Xiaohua Wu, M.D.&Ph.D

  Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 26, 2021
• Study Start: February 11, 2021
• Primary Completion: August 22, 2022
• Study Completion: December 31, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

CN (1)