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Clinical Trial of 12 microRNAs detection kit (fluorescence RT-PCR method)

Clinical Trial of 12 microRNAs detection kit (fluorescence RT-PCR method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085635
Enrollment
Unknown
Registered
2024-06-14
Start date
2021-12-24
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Gold Standard:gastro-endoscope and / or pathology testing reports
Index test:12 microRNAs detection kit (fluorescence RT-PCR method)

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Prospective enrolled patients must fulfill all the following requirements 1.Clinically regarded as high-risk for gastric cancer To be classified as high-risk for gastric cancer, (i) must be satisfied, and in the same time, one of (ii) to (vii) must also be satisfied. (i)Above 40 years of age, both males and females are accepted (ii)Lives in regions with high-incidence gastric cancer (iii)HP infected (iv)Known to have history of pre-cancerous diseases, such as chronic atrophic gastritis, gastric ulcer, gastric polyps, Remnant stomach after surgery, hypertrophic gastritis, and pernicious anemia. (v)First degree relative with known gastric cancer patient (vi)With other high-risk factors (High salt in food, preserved food, smoking, heavy alcohol use) (vii)With symptoms for upper GI, for example, one of the following symptoms: Upper abdominal fullness and discomfort, acid reflux, nausea, belching, loss of appetite, stomachache etc. 2.Able to collect blood before gastro-endoscope, with minimal volume of 10 ml of peripheral venous blood. 3.Individuals can provide signed ICF. Retrospectively enrolled patients (enrolled after diagnosis) must fulfill all the following requirements: 1.Above 40 years of age, both males and females are accepted. 2.Confirmed by gastro-endoscope and / or pathology report as gastric cancer patient. 3.Able to donate blood before surgery or other anti-cancer treatment with a minimum of 10 ml venous blood. 4.Able to provide signed ICF Interference Group must satisfy all of the following conditions: 1.Clinically Regarded as Interference Group, which must satisfy subcondition (i) and one of the subconditions (ii) to (vii) (i)Aged 40 years and above, either male or female (ii)Clinically or pathologically diagnosed as lung cancer patient, but no surgery or anti-cancer treatment has been performed. (iii)Clinically or pathologically diagnosed as breast cancer patient, but no surgery or anti-cancer treatment has been performed. (iv)Clinically or pathologically diagnosed as liver cancer patient, but no surgery or anti-cancer treatment has been performed. (v)Clinically or pathologically diagnosed as thyroid cancer patient, but no surgery or anti-cancer treatment has been performed. (vi)Clinically or pathologically diagnosed as colorectal cancer patient, but no surgery or anti-cancer treatment has been performed. (vii)Clinically or pathologically diagnosed as esophageal cancer patient, but no surgery or anti-cancer treatment has been performed. 2.Able to donate blood before surgery or other anti-cancer treatment with a minimum of 10 ml venous blood. 3.Able to provide signed ICF

Exclusion criteria

Exclusion criteria: 1.Subject undergoing anti-cancer treatment or has been treated for cancer before enrollment. 2.Subject has Contraindications for phlebotomy. 3.Investigators have decided that the subject is not fit for this study.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;accuracy;

Secondary

MeasureTime frame
positive predicative value;negative predictive value;

Countries

China

Contacts

Public ContactXun Li

The First Hospital of Lanzhou University

lxdr21@126.com+86 139 9313 8612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026