Status:
UNKNOWN
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Guangzhou Burning Rock Bioengineering Ltd.
Conditions:
Cancer
Eligibility:
All Genders
40-75 years
Brief Summary
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Cancer Arm Participants:
- Age 40-75 years at the day of consenting to the study.
- Able to provide a written informed consent.
- No prior cancer treatment (local or systematic) with either of the following:
- A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.
- B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
- Exclusion Criteria for Cancer Arm Participants:
- Insufficient qualified blood samples.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 7 days prior to blood draw.
- Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
- With other known malignant tumors or multiple primary tumors.
- Inclusion Criteria for Benign Disease Arm Participants:
- Age 40-75 years at the day of consenting to the study.
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- Have either of the following:
- A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.
- B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.
- Exclusion Criteria for Benign Disease 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 7 days prior to study blood draw.
- Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
Exclusion
Key Trial Info
Start Date :
January 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 22 2022
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT05224596
Start Date
January 18 2021
End Date
September 22 2022
Last Update
February 28 2022
Active Locations (1)
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1
ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, China, 200032