Esophageal NeoplasmsNCT05680077
KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
An observational study of Esophageal Neoplasms, run by Wuhan Ammunition Life-tech Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
- How many people
- 1,116 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2022to 31 Oct 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Naval Military Medical University
Shanghai
About this study
Official title: Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Esophageal Cancer/Precancerous Lesions: a Clinical Trial
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:
- How consistent are the test results of the kit with the clinical reference diagnostic criteria?
- 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.
Read the detailed description
Esophageal carcinoma is caused by abnormal hyperplasia of the squamous or glandular epithelium, the main pathological types are squamous cell carcinoma and adenocarcinoma. Globally, esophageal cancer has the seventh highest incidence and the sixth leading cause of cancer death. Statistics showed that in 2020, there were 604,000 new cases of esophageal cancer and 54.4 deaths.
The 5-year survival rates were significantly different in esophageal carcinomas of different stages, for example, it's 84.9% for stage Ia, 70.9% for stage Ib, 56.2% for stage IIa, 43.3% for stage IIb, 37.9% for stage IIIa, 23.3% for stage IIIb, 12.9% for stage IIIc and 3.4% for stage IV. Therefore, early diagnosis and treatment is most effective strategy to reduce the incidence and mortality of esophageal cancer.
Endoscopy and pathological biopsy are currently the "golden standard" for diagnosing esophageal cancer, however, limited by medical resources, tolerance and other issues, population screening by endoscopy is not cost-effective and applicable. There is no recognized and effective serologic marker for the detection of early esophageal carcinoma and precancerous lesions, the effect of multiple serological markers combined detection is better than that of single markers, and the accuracy were 74%~85% , but it is still suboptimal.
Methylation of the tumor suppressor gene promoter region CpG island is the most common change during tumorgenesis, studies showed that methylation events could occur at the early stages of esophageal cancer.
Circulating tumor DNA (ctDNA) is derived from DNA fragments produced by apoptosis, necrosis or secretion of tumor cells, which is a part of circulating free (cfDNA). CtDNA contains the same gene defects as its source tumor DNA, such as point mutation, rearrangement, amplification, microsatellite change, epigenetic modification, etc.
KCNA3 is a member of the protein family that encodes potassium channels and mainly affects cell viscosity. OTOP2 is a member of the protein family encoding proton transport channels, some studies have shown that the methylation levels of two genes in esophageal cancer tissues were significantly higher than that in adjacent tissues, and they can be used as a potential marker for the diagnosis of esophageal cancer.
This kit is based on real-time fluorescence PCR technology to achieve the qualitative detection of KCNA3 and OTOP2 methylation in plasma samples. Before PCR amplification, cfDNA was transformed by bisulfite and ACTB (β-Actin) gene is used us the internal reference.
- Conditions
- Esophageal Neoplasms
- Being tested
- KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
- Keywords
- Esophageal carcinoma, Esophageal high-grade intraepithelial neoplasia, methylation, Fluorescent PCR
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive group | Esophageal carcinoma and high-grade intraepithelial neoplasia patients. Receives: 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.). Receives: Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the procedure
Secondary outcomes (1)
reliability
In this study, the reliability evaluation included two indicators, namely the agreement rate of methylation detection with Sanger sequencing, and the Kappa value of the two methods
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start28 Oct 2022
- Primary completion30 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,116 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Wuhan Ammunition Life-tech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital
- Responsible party
- Sponsor
- Investigators
- Luowei Wang, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680077
- Sponsor's protocol ID
- AD10
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential information of the individual participant will be retained by investigators and clinical trial institutions, any personal information of subjects will not be disclosed in reports, publications, etc. Direct access to source data and and files is only allowed for the purpose of monitoring, auditing or inspection, without revealing the subject's privacy. The medical products administration may inspect the basic documents of clinical trials of medical devices in order to confirm the authenticity and the integrity of the collected data.
Publications
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.
PubMed 33538338Wang 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.
PubMed 15647178di 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.
PubMed 28778650Wang 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.
PubMed 25561808Talukdar 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.
PubMed 33741694Qin 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.
PubMed 31527170Cao 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.
PubMed 32699215Tu 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.
PubMed 29371428
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Esophageal Cancer/Precancerous Lesions: a Clinical Trial
- ClinicalTrials.gov ID
- NCT05680077
- Acronym / sponsor ID
- AD10
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal carcinoma, Esophageal high-grade intraepithelial neoplasia, methylation, Fluorescent PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- Wuhan Ammunition Life-tech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How consistent are the test results of the kit with the clinical reference diagnostic criteria?
- 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.
Detailed description
Esophageal carcinoma is caused by abnormal hyperplasia of the squamous or glandular epithelium, the main pathological types are squamous cell carcinoma and adenocarcinoma. Globally, esophageal cancer has the seventh highest incidence and the sixth leading cause of cancer death. Statistics showed that in 2020, there were 604,000 new cases of esophageal cancer and 54.4 deaths.
The 5-year survival rates were significantly different in esophageal carcinomas of different stages, for example, it's 84.9% for stage Ia, 70.9% for stage Ib, 56.2% for stage IIa, 43.3% for stage IIb, 37.9% for stage IIIa, 23.3% for stage IIIb, 12.9% for stage IIIc and 3.4% for stage IV. Therefore, early diagnosis and treatment is most effective strategy to reduce the incidence and mortality of esophageal cancer.
Endoscopy and pathological biopsy are currently the "golden standard" for diagnosing esophageal cancer, however, limited by medical resources, tolerance and other issues, population screening by endoscopy is not cost-effective and applicable. There is no recognized and effective serologic marker for the detection of early esophageal carcinoma and precancerous lesions, the effect of multiple serological markers combined detection is better than that of single markers, and the accuracy were 74%~85% , but it is still suboptimal.
Methylation of the tumor suppressor gene promoter region CpG island is the most common change during tumorgenesis, studies showed that methylation events could occur at the early stages of esophageal cancer.
Circulating tumor DNA (ctDNA) is derived from DNA fragments produced by apoptosis, necrosis or secretion of tumor cells, which is a part of circulating free (cfDNA). CtDNA contains the same gene defects as its source tumor DNA, such as point mutation, rearrangement, amplification, microsatellite change, epigenetic modification, etc.
KCNA3 is a member of the protein family that encodes potassium channels and mainly affects cell viscosity. OTOP2 is a member of the protein family encoding proton transport channels, some studies have shown that the methylation levels of two genes in esophageal cancer tissues were significantly higher than that in adjacent tissues, and they can be used as a potential marker for the diagnosis of esophageal cancer.
This kit is based on real-time fluorescence PCR technology to achieve the qualitative detection of KCNA3 and OTOP2 methylation in plasma samples. Before PCR amplification, cfDNA was transformed by bisulfite and ACTB (β-Actin) gene is used us the internal reference.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive group | – | Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)Esophageal carcinoma and high-grade intraepithelial neoplasia patients. |
| Negative group | – | Diagnostic Test: KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)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.). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)Blood samples from participants in both groups were collected and methylation tests were performed according to the kit instructions. | Diagnostic test | Negative group, Positive group |
Primary outcome
validity
Time frame: Immediately after the procedure
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.
1 secondary outcome
reliability
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 33538338Sung 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.
- Background: PubMed 15647178Wang 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.
- Background: PubMed 28778650di 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.
- Background: PubMed 25561808Wang 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.
- Background: PubMed 33741694Talukdar 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.
- Background: PubMed 31527170Qin 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.
- Background: PubMed 32699215Cao 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.
- Background: PubMed 29371428Tu 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.
- Individual participant dataSharing planned: No. Confidential information of the individual participant will be retained by investigators and clinical trial institutions, any personal information of subjects will not be disclosed in reports, publications, etc. Direct access to source data and and files is only allowed for the purpose of monitoring, auditing or inspection, without revealing the subject's privacy. The medical products administration may inspect the basic documents of clinical trials of medical devices in order to confirm the authenticity and the integrity of the collected data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luowei Wang, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms, run by Wuhan Ammunition Life-tech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680077, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.