Clinical trial NCT06232395: Early Detection and Post-operative Monitoring of Gastric Cancer
Official title: Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Suzhou Huhu Health & Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fudan University
First posted: 2024-01-30
Enrollment: 1197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 1197subjects are targeted to enroll.

Brief summary: This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.

Detailed description: This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.

This study is a prospective and multi-center study.

Eligibility criteria: Inclusion Criteria:

1. Subject age over 18.
2. Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
3. Subject has or will have gastroscopy and/or pathological examination results at this center.
4. Subject must be able to fully understand the informed consent form and be able to personally sign it.

Exclusion Criteria:

1. Subject has serious heart, liver, kidney dysfunction, or mental illness.
2. Subject diagnosed previously with any kind of malignant tumor.
3. Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
4. Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
5. Researchers believe that subject is not suitable for enrollment.
6. Subject can not supply sufficient sample to complete this experiment.

Primary outcomes:
measure: The performance of the new detection system for gastric cancer (GC) detection
timeFrame: 2 years
measure: The performance of the new biomarkers in the post-operative monitoring of gastric cancer
timeFrame: 2 years
Secondary outcomes:
measure: Compare the performance of the new biomarkers for GC detection with the conventional tumor markers
timeFrame: 2 years
measure: The performance of the new biomarkers as prognostic biomarkers
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center.
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center.
state: Shanghai
Study officials:
References: