NCT05347524 Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study
| NCT ID | NCT05347524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 384 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 384 participants in total. It began in 2022-03-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Yihong Sun, Ph. D
PRINCIPAL INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai, China
Frequently Asked Questions
Who can join the NCT05347524 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05347524 currently recruiting?
Yes, NCT05347524 is actively recruiting participants. Contact the research team at sun.yihong@zs-hospital.sh.cn for enrollment information.
Where is the NCT05347524 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05347524 clinical trial?
NCT05347524 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Yihong Sun, Ph. D at Zhongshan Hospital, Fudan University, Shanghai, China. The trial plans to enroll 384 participants.
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