KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)

NCT05680077 | Completed DMC

• 1 other identifier: AD10
• Study Type: observational
• Target: 1,116
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.How consistent are the test results of the kit with the clinical reference diagnostic criteria?
2. 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.

Conditions

Esophageal Neoplasms

Keywords

Esophageal carcinoma; Esophageal high-grade intraepithelial neoplasia; methylation; Fluorescent PCR

Outcome Measures

Primary Outcomes (1)

• validity

  In this study, validity indicates the consistency of methylation test with the golden diagnostic standards, including sensitivity and specificity. Sensitivity indicates the proportion of methylation-positive samples in esophageal cancer/high-grade neoplasia samples. Specificity indicates the proportion of methylation-negative samples in non-esophageal cancer/high-grade neoplasia.

  Immediately after the procedure

Secondary Outcomes (1)

• reliability

  Immediately after the procedure

Study Arms (2)

Positive group

Esophageal carcinoma and high-grade intraepithelial neoplasia patients.

Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)

Negative group

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.).

Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)

Interventions

KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method) DIAGNOSTIC_TEST

Blood samples from participants in both groups were collected and methylation tests were performed according to the kit instructions.

Negative group; Positive group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Esophageal cancer patients, number ≥ 300, containing different TNM stages. 2. Esophageal high-grade intraepithelial neoplasis patients, number ≥70. 3. Patients with benign diseases of digestive system including esophagitis, gastritis, enteritis, appendicitis, gastric polyps, colorectal polyps, etc. , number ≥200. 4. 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.)， number ≥350. 5. All the enrolled participants should be ≥1000.

You may qualify if:

• 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.
• patients with benign diseases of digestive system who have undergone endoscopy (including esophagitis, gastritis, enteritis, appendicitis, gastric polyps, colorectal polyps, etc.).
• 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.

You may not qualify if:

• patients who have received anti-tumor therapy such as radiotherapy/chemotherapy;
• Esophageal carcinoma and high-grade intraepithelial neoplasia patients who were also suffering from other malignant tumors;
• Samples not kept as required or samples of hemolysis;
• The sample volume fails to meet the detection requirements;
• Esophageal carcinoma patients with distant metastasis.

Sponsors & Collaborators

• Wuhan Ammunition Life-tech Co., Ltd: lead
• Changhai Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Naval Military Medical University

Shanghai, China

Location

Related Publications (8)

• Sung 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 BACKGROUND

• Wang 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 BACKGROUND

• di 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 BACKGROUND

• Wang 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 BACKGROUND

• Talukdar 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 BACKGROUND

• Qin 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.

  PMID: 31527170 BACKGROUND

• Cao W, Lee H, Wu W, Zaman A, McCorkle S, Yan M, Chen J, Xing Q, Sinnott-Armstrong N, Xu H, Sailani MR, Tang W, Cui Y, Liu J, Guan H, Lv P, Sun X, Sun L, Han P, Lou Y, Chang J, Wang J, Gao Y, Guo J, Schenk G, Shain AH, Biddle FG, Collisson E, Snyder M, Bivona TG. Multi-faceted epigenetic dysregulation of gene expression promotes esophageal squamous cell carcinoma. Nat Commun. 2020 Jul 22;11(1):3675. doi: 10.1038/s41467-020-17227-z.

  PMID: 32699215 BACKGROUND

• Tu YH, Cooper AJ, Teng B, Chang RB, Artiga DJ, Turner HN, Mulhall EM, Ye W, Smith AD, Liman ER. An evolutionarily conserved gene family encodes proton-selective ion channels. Science. 2018 Mar 2;359(6379):1047-1050. doi: 10.1126/science.aao3264. Epub 2018 Jan 25.

  PMID: 29371428 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

human blood samples

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Luowei Wang, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 11, 2023
• Study Start: October 28, 2022
• Primary Completion: August 30, 2023
• Study Completion: October 31, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)