NCT04385316

Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy

Status unknown Last updated 12 May 2020

What this trial tests

trial testing DNA extraction of samples and high-throughput sequencing of small panels in Gastric Cancer in 3 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	3
Start date	1 September 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• DNA extraction of samples and high-throughput sequencing of small panels
• DNA extraction of samples and high-throughput sequencing of small panels
• DNA extraction of samples and high-throughput sequencing of small panels

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Eligibility, any sex, with Gastric Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastric cancer and colorectal cancer are common gastrointestinal malignancies in the world.Early cancer generally has no obvious symptoms. Endoscopy is the "gold standard"for the diagnosis of gastric cancer and colorectal cancer.gastric cancer and colorectal cancer treatment mainly includes surgery and medication.Compared with traditional diagnosis and treatment methods, the application of gene detection technology, especially high-throughput sequencing technology (NGS) in tumor diagnosis and treatment, performs multi-dimensional and multi-target detection of cancer-related genes, which can quickly and accurately determine the target gene mutations Morphology and expression differences, so as to provide personalized guidance to patients in terms of medication, treatment or prognosis evaluation, which can save a lot of time and treatment costs, and improve the overall treatment effect and patient quality of life.

Cystoscopy and biopsy sampling pathological testing are the gold standard for bladder cancer diagnosis, and have been widely used in clinical diagnosis and prognosis judgment. However, cystoscopy is cumbersome, expensive, and often causes pain to the patients under test. At present, the main clinical non-invasive detection technique for bladder cancer is still the cytological examination of urinary tract bladder cells in urine, and its sensitivity and specificity are not good, especially for the diagnosis of early lower grade bladder cancer.For bladder cancer, tumor tissue (puncture biopsy or surgical resection) DNA, urine ctDNA, urinary tract exfoliated cell DNA and peripheral blood ctDNA can be used for genetic testing, but the consistency of the genetic testing results of these four types of samples has not been verified, especially There is no systematic evaluation of the guidance effect of non-invasive gene detection of free tumor DNA and urinary tract shed cell DNA in the diagnosis and treatment of bladder cancer.The corresponding relationship between the significant mutation genes contained in the DNA derived from bladder urinary tract cancer and the various types and stages of bladder cancer is not clear.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Liquid biopsy in gastric cancer: predictive and prognostic biomarkers.
   Zhang Z, Wu H, Chong W, Shang L, et al · · 2022 · cited 84× · PMID 36302755 · DOI 10.1038/s41419-022-05350-2
2. Clinical applications and perspectives of circulating tumor DNA in gastric cancer.
   Li JH, Zhang DY, Zhu JM, Dong L. · · 2024 · cited 14× · PMID 38184573 · DOI 10.1186/s12935-024-03209-4