Clinical trial · Observational
KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Esophageal Cancer/Precancerous Lesions: a Clinical Trial
NCT05680077CI-TRIAL-00073986completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to test the clinical efficacy of "KCNA3 and OTOP2 gene methylation combined detection kit (fluorescence PCR method)"in esophageal cancer and high-grade esophageal neoplasia auxiliary diagnosis.The main questions it aims to answer are: 1. How consistent are the test results of the kit with the clinical reference diagnostic criteria? 2. Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting KCNA3 and OTOP2 gene methylation. Each participant is required to provide no less than 10 ml of blood to complete the kit test.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Positive group
- description
- Esophageal carcinoma and high-grade intraepithelial neoplasia patients.
- interventionNames
- Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
- label
- Negative group
- description
- Patients with other digestive malignancies (including gastric cancer, colorectal cancer, liver cancer, pancreatic cancer,Cholangiocarcinoma, etc.) and patients with non-digestive malignant tumors (including thyroid cancer, lung squamous cell carcinoma, cervix Cancer, endometrial cancer, breast cancer, prostate cancer, etc.), Patients with benign digestive disorders (including esophagitis, gastritis, enteritis, appendicitis, gastric polyps, colorectal polyps, etc.).
- interventionNames
- Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
Primary outcomes (1)
- measure
- validity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. esophageal carcinoma patients confirmed or highly suspected by endoscopy, imaging examination or pathological biopsy, and high-grade intraepithelial neoplasia of the esophagus patients mainly enrolled from individuals who planned to undergo radical esophagectomy of esophageal cancer, endoscopic submucosal dissection or primary chemoradiotherapy. 2. patients with benign diseases of digestive system who have undergone endoscopy (including esophagitis, gastritis, enteritis, appendicitis, gastric polyps, colorectal polyps, etc.). 3. Untreated patients with other digestive system malignancies (including gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, bile duct cancer, etc.) and patients with non-digestive system malignancies (including thyroid cancer, lung squamous cell carcinoma, cervical cancer, endometrial cancer, breast cancer, prostate cancer, etc.) confirmed by clinical reference diagnostic criteria. Exclusion Criteria: 1. patients who have received anti-tumor therapy such as radiotherapy/chemotherapy; 2. Esophageal carcinoma and high-grade intraepithelial neoplasia patients who were also suffering from other malignant tumors; 3. Samples not kept as required or samples of hemolysis; 4. The sample volume fails to meet the detection requirements; 5. Esophageal carcinoma patients with distant metastasis.
References
Publications (8)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDWang GQ, Abnet CC, Shen Q, Lewin KJ, Sun XD, Roth MJ, Qiao YL, Mark SD, Dong ZW, Taylor PR, Dawsey SM. Histological precursors of oesophageal squamous cell carcinoma: results from a 13 year prospective follow up study in a high risk population. Gut. 2005 Feb;54(2):187-92. doi: 10.1136/gut.2004.046631. PMID 15647178
- BACKGROUNDdi Pietro M, Canto MI, Fitzgerald RC. Endoscopic Management of Early Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus: Screening, Diagnosis, and Therapy. Gastroenterology. 2018 Jan;154(2):421-436. doi: 10.1053/j.gastro.2017.07.041. Epub 2017 Aug 2. PMID 28778650
- BACKGROUNDWang J, Wu N, Zheng QF, Yan S, Lv C, Li SL, Yang Y. Evaluation of the 7th edition of the TNM classification in patients with resected esophageal squamous cell carcinoma. World J Gastroenterol. 2014 Dec 28;20(48):18397-403. doi: 10.3748/wjg.v20.i48.18397. PMID 25561808
- BACKGROUNDTalukdar FR, Soares Lima SC, Khoueiry R, Laskar RS, Cuenin C, Sorroche BP, Boisson AC, Abedi-Ardekani B, Carreira C, Menya D, Dzamalala CP, Assefa M, Aseffa A, Miranda-Goncalves V, Jeronimo C, Henrique RM, Shakeri R, Malekzadeh R, Gasmelseed N, Ellaithi M, Gangane N, Middleton DRS, Le Calvez-Kelm F, Ghantous A, Roux ML, Schuz J, McCormack V, Parker MI, Pinto LFR, Herceg Z. Genome-Wide DNA Methylation Profiling of Esophageal Squamous Cell Carcinoma from Global High-Incidence Regions Identifies Crucial Genes and Potential Cancer Markers. Cancer Res. 2021 May 15;81(10):2612-2624. doi: 10.1158/0008-5472.CAN-20-3445. Epub 2021 Mar 19. PMID 33741694
- BACKGROUNDQin Y, Wu CW, Taylor WR, Sawas T, Burger KN, Mahoney DW, Sun Z, Yab TC, Lidgard GP, Allawi HT, Buttar NS, Smyrk TC, Iyer PG, Katzka DA, Ahlquist DA, Kisiel JB. Discovery, Validation, and Application of Novel Methylated DNA Markers for Detection of Esophageal Cancer in Plasma. Clin Cancer Res. 2019 Dec 15;25(24):7396-7404. doi: 10.1158/1078-0432.CCR-19-0740. Epub 2019 Sep 16.