Clinical trial NCT04903665: PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I
Official title: Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Cancer
Keywords: gynecologic cancer
early detection
liquid biopsy
cell-free DNA
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Bioengineering Ltd.
First posted: 2021-05-26
Enrollment: 495
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.
timeFrame: 12 months
Secondary outcomes:
measure: Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages.
timeFrame: 12 months
measure: Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
name: Xiaohua Wu, M.D.&Ph.D
role: PRINCIPAL_INVESTIGATOR
References: