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

NCT06001099 | Unknown

• 1 other identifier: RSCD2021002
• Study Type: observational
• Target: 2,935
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.

  24months

• To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors

  24months

Study Arms (2)

Cancer arm

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

Healthy arm

Participants without a known cancer or certain benign disease, from whom blood samples will be collected

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• 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 healthy controls

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 within 42 days prior to blood collection
• 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.
• 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;
• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, white blood cells

Study Officials

• Xiaohua Wu, MD.&PHD

  Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Wen, MD.&PHD

CONTACT

+86-021-64175590; wenhao_fdc@163.com

Yuzi Zhang, MD

CONTACT

+86-021-60293798; Z_Zhangyuzi@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: February 22, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)