Clinical trial NCT06001099: PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II
Official title: Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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 Dx Co., Ltd.
First posted: 2023-08-21
Enrollment: 2935
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 healthy controls

Brief summary: This study is a prospective study aimed to 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 2935 female participants, including participants with gynecologic cancers patients and healthy participants.


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 within 42 days prior to blood collection
* 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.
* previous history of malignant tumor;
* precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;
* unknown or insufficient to determine the nature of the lesion by histopathological reports;

Inclusion Criteria for healthy control Arm Participants:

* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* No cancer related symptoms within 30 days prior to study screening.
* Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for healthy control Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 30 days prior to study blood draw.
* Recipient of anti-infectious therapy within 14 days prior to study blood draw.
* Have received or are undergoing curative cancer treatment within three years prior to study screening.
* With autoimmune or other diseases with severe comorbidities.

Primary outcomes:
measure: To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
timeFrame: 24 months
Secondary outcomes:
measure: To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.
timeFrame: 24months
measure: To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors
timeFrame: 24months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan university shanghai cancer center, Deparment of gynecologic oncology
state: Shanghai
Study officials:
affiliation: Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
name: Xiaohua Wu, MD.&PHD
role: PRINCIPAL_INVESTIGATOR
References: