Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses: Baseline blood draw and blood-based biomarkers analyses
Study summary
This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-based biomarkers. The study will enroll 384 participants with gastric cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria:
* Inclusion Criteria for Case Arm Participants:
1. Age 18-74 years at the day of consenting to the study.
2. Able to provide a written informed consent.
3. No prior cancer treatment (local or systematic) with either of the following:
A. Pathologically confirmed gastric 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.
4. Diagnosis of peritoneal metastasis by laparoscopy with cytology.
* Inclusion Criteria for Control Arm Participants:
1. Age 18-74 years at the day of consenting to the study.
2. Able to provide a written informed consent.
3. No prior cancer treatment (local or systematic) with either of the following:
A. Pathologically confirmed gastric 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.
4. No peritoneal metastasis detected by laparoscopy with cytology.
Exclusion Criteria:
* Exclusion Criteria for All Participants:
1. Insufficient qualified blood samples.
2. During pregnancy or lactation.
3. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
4. Recipient of blood transfusion within 7 days prior to blood draw.
5. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
6. With other known malignant tumors or multiple primary tumors.
* Exclusion Criteria for Control Arm Participants:
1. Insufficient qualified blood samples.
2. During pregnancy or lactation.
3. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
4. Recipient of blood transfusion within 7 days prior to blood draw.
5. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
6. With other known malignant tumors or multiple primary tumors.
Primary outcome measure(s)
Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer. — 30 months
Sensitivity and specificity of a cfDNA methylation-based model, in combination with other biomarkers, for detecting peritoneal metastasis of gastric cancer. — 30 months
Trial sites (1)
Facility
City
Region
Status
ZhongShan Hospital, Fudan university, Shanghai, China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.