Gynecologic Cancer
Conditions
Keywords
gynecologic cancer, early detection, liquid biopsy, cell-free DNA
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.
Interventions
None listed
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Fudan University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHao Wen, MD.&PHD
Backup ContactYuzi Zhang, MD
Outcome results
None listed