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

Gynecologic Cancer Clinical Trial

Official title:

Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001099
• Other study ID #: RSCD2021002
• Status: Recruiting
• Start date: February 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Fudan University
• Contact: Hao Wen, MD.&PHD
• Phone: +86-021-64175590
• Email: wenhao_fdc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2935
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 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.

Related Conditions & MeSH terms

• Gynecologic Cancer

Locations

Country	Name	City	State
China	Fudan university shanghai cancer center, Deparment of gynecologic oncology	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 months
Secondary	To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.		24months
Secondary	To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors		24months