NCT05347524Recruiting
Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study
Source: ClinicalTrials.gov · Last updated 26 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 384 (estimated)
- First submitted
- 21 Apr 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05347524
What you commit to
- Study type: Observational
- Planned participants: 384
- From 1 Mar 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exclusion Criteria for All 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.
- Exclusion Criteria for Control 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.
Who the study is looking for
- 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:
- Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.
- 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:
- Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.
- 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.
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital, Fudan University, Shanghai, China Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.