Clinical Trials Logo

Clinical Trial Summary

i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.

ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.

iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.


Clinical Trial Description

Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.

Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01642797
Study type Interventional
Source Shandong University
Contact Yanqing Li, PhD. MD.
Phone 86-531-8216923
Email qiluliyanqign@gmail.com
Status Not yet recruiting
Phase N/A
Start date August 2012
Completion date September 2013

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04602026 - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer N/A
Not yet recruiting NCT03599778 - XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma Phase 1/Phase 2
Terminated NCT00256321 - Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma Phase 2
Recruiting NCT04147494 - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Early Phase 1
Recruiting NCT02617134 - CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor Phase 1/Phase 2
Recruiting NCT02317471 - Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96 Phase 1/Phase 2
Active, not recruiting NCT03735511 - A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
Recruiting NCT04410302 - Patient-Derived Xenografts to Reduce Cancer Health Disparities
Recruiting NCT05596188 - Anxiety Before Non-cardiac Surgery in Adults
Recruiting NCT02611024 - Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors Phase 1/Phase 2
Terminated NCT04254107 - A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer Phase 1
Recruiting NCT01348009 - Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer Phase 1/Phase 2
Recruiting NCT00639522 - Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma Phase 1
Recruiting NCT05811546 - Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
Recruiting NCT05229809 - Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer Phase 4
Recruiting NCT02409199 - A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer Phase 2/Phase 3
Completed NCT00970138 - Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer Phase 2/Phase 3
Recruiting NCT06408220 - Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer N/A
Recruiting NCT04443036 - Clinical Study of Nab-paclitaxel Combined With Toripalimab in Local Advanced or Metastatic G/GEJ Carcinoma N/A
Active, not recruiting NCT04505553 - Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer Phase 2