Early detection of gynecologic cancers using various biomarkers
Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study
This study is testing if new blood tests can help find gynecologic cancers earlier in women by looking at different biological markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2935 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06001099 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the effectiveness of multi-omics assays for the early detection of gynecologic cancers in female participants. It will evaluate biomarkers such as cell-free DNA methylation, circulating tumor DNA mutations, and blood microRNA markers. Approximately 2,935 female participants will be enrolled, including those diagnosed with gynecologic cancers and healthy controls. The study will focus on comparing the performance of these biomarkers to improve early detection rates.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 years or older with a confirmed diagnosis or high suspicion of gynecologic malignancies.
Not a fit: Patients who are pregnant, lactating, or have received recent anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance early detection of gynecologic cancers, leading to improved patient outcomes.
How similar studies have performed: Other studies utilizing similar multi-omics approaches for cancer detection have shown promising results, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai
- Fudan university shanghai cancer center, Deparment of gynecologic oncology — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xiaohua Wu, MD.&PHD — Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
- Study coordinator: Hao Wen, MD.&PHD
- Email: wenhao_fdc@163.com
- Phone: +86-021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.