Clinical trial NCT06776835: Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer
Official title: Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer and Exploring Its Correlation With Prognostic Diagnosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Stomach Neoplasms
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Jiangsu Cancer Institute & Hospital
name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
First posted: 2025-01-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AFFILIATED HOSPITAL OF NANTONG UNIVERSITY

Brief summary: Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early. Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as an auxiliary diagnostic biomarker for gastric cancer.

Detailed description: Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early.

Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated by previous scientific researches that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as a new biomarker panel for gastric cancer.

The purpose of the present clinical trail is to explore the correlation between small non-coding RNAs panel and early gastric cancer, and to elucidate the possibility of small non-coding RNAs panel as a biomarker for gastric cancer. Verify the experimental purpose by monitoring the relative quantification of small non-coding RNAs panel through high-throughput sequencing and qRT PCR technology.

Eligibility criteria: Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old and ≤ 85 years old
* Histologically confirmed gastric cancer

Exclusion Criteria:

* Other previous malignancy within 5 year
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
* Pregnancy or lactation period
* Legal incapacity

Primary outcomes:
measure: Analysis of relative quantitative of small non-coding RNAs
timeFrame: an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
References: