Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
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• Inclusion Criteria for Case Arm Participants:

‣ Age 18-74 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 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.

⁃ Diagnosis of peritoneal metastasis by laparoscopy with cytology.

• Inclusion Criteria for Control Arm Participants:

‣ Age 18-74 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 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.

⁃ No peritoneal metastasis detected by laparoscopy with cytology.

Locations
Other Locations
China
ZhongShan Hospital, Fudan university, Shanghai, China
RECRUITING
Shanghai
Contact Information
Primary
Yihong Sun, Ph. D
sun.yihong@zs-hospital.sh.cn
+86-021-65642662
Backup
Xuefei Wang, Ph. D
wang.xuefei@zs-hospital.sh.cn
+86-021-65642662
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 384
Treatments
Case arm - Gastric cancer with peritoneal metastasis
Baseline blood samples will be collected from gastric cancer participants with peritoneal metastasis.
Control arm - Gastric cancer without peritoneal metastasis
Baseline blood samples will be collected from gastric cancer participants without peritoneal metastasis.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital
Collaborators: Guangzhou Burning Rock Bioengineering Ltd.

This content was sourced from clinicaltrials.gov