To hear about similar clinical trials, please enter your email below
Trial Title:
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II
NCT ID:
NCT06001099
Condition:
Gynecologic Cancer
Conditions: Keywords:
gynecologic cancer
early detection
liquid biopsy
cell-free DNA
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Wen, MD.&PHD
Phone:
+86-021-64175590
Phone ext:
81007
Email:
wenhao_fdc@163.com
Contact backup:
Last name:
Yuzi Zhang, M.D
Phone:
+86-021-60293798
Email:
Z_Zhangyuzi@163.com
Investigator:
Last name:
Xiaohua Wu, MD.&PHD
Email:
Principal Investigator
Start date:
February 22, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Dx 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/NCT06001099
