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Trial Title:
Liquid Biopsy-based Early Detection of Ovarian Cancer: a Proof-of-concept Study ( PROFOUND-OC )
NCT ID:
NCT06249308
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood collection
Description:
Blood sample will be collected
Arm group label:
Ovarian cancer
Summary:
This study is a multi-center, observational study aiming at developing a machine
learning-based early detection model using prospectively collected liquid biopsy samples
from newly diagnosed ovarian cancer.
Detailed description:
Peripheral blood samples from ovarian cancer (OC) patients will be prospectively
collected to identify cancer-specific circulating signals by analyzing cell free DNA.
Based on the comprehensive molecular profiling, a machine learning-driven noninvasive
test will be trained and validated through a two-stage approach in clinically annotated
individuals. Approximately 168 stage I-II OC patients will be enrolled in this study.
Age-matched female controls included in model development were recruited in another
study, which are volunteers without a cancer diagnosis after routine medical screening.
Criteria for eligibility:
Study pop:
Patients diagnosed ovarian cancer or individuals with a high suspicion for OC will be
invited to participate in this proof-of-concept study
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 40-75 years old
- Clinically and/or pathologically diagnosed ovarian cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not
limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted
therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of
the protocol procedures
Exclusion Criteria:
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile
illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell
transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
- Recipients of therapy in past 14 days prior to blood draw, including oral or IV
antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine,
arsenic trioxide
- Other conditions that the investigators considered are not suitable for the
enrollment
Gender:
Female
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
110042
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huaiwu Lu, M.D., Ph.D.
Phone:
+8618688395806
Email:
luhuaiwu@163.com
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhuo Yang, M.D., Ph.D.
Phone:
+8618940258361
Email:
yangzhuo@cancerhosp-ln-cmu.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Wen, M.D., Ph.D.
Phone:
+8618017317873
Email:
wenhao_fdc@163.com
Start date:
December 18, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Weihe Medical Laboratory Co., Ltd.
Agency class:
Industry
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06249308
