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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000001676 |
Receipt No. | R000002024 |
Scientific Title | Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma |
Date of disclosure of the study information | 2009/01/31 |
Last modified on | 2011/04/19 |
Basic information | ||
Public title | Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma | |
Acronym | Follow up study after EMR for esophageal squamous cell carcinoma | |
Scientific Title | Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma | |
Scientific Title:Acronym | Follow up study after EMR for esophageal squamous cell carcinoma | |
Region |
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Condition | |||
Condition | Esophageal squamous cell carcinoma | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Previous studies have reported that multiple Lugol-voiding lesions of the background esophageal mucosa are associated with a very high risk of multiple cancers in the esophagus, as well as the head and neck region. The ability to use Lugol-voiding pattern as a biomarker for the risk of second primary cancers in the esophagus and head and neck region after endoscopic mucosal resection (EMR) in patients with esophageal cancer would facilitate the early detection and treatment of metachronous multiple cancers, contribute to improved outcomes of EMR, and thereby approach a more ideal surveillance period after EMR. |
Basic objectives2 | Others |
Basic objectives -Others | The aim of this study is to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma. |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The cumulative incidence of metachronous multiple cancers of the esophagus as assessed by the Lugol-voiding pattern. |
Key secondary outcomes | 1) The total annual number of cases of metachronous multiple cancer of the esophagus as assessed by the Lugol-voiding pattern.
2) The cumulative incidence of metachronous multiple cancers of the head and neck region as assessed by the Lugol-voiding pattern. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | At study entry, patients will be instructed to abstain from smoking and drinking alcohol. | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Newly diagnosed early squamous cell carcinoma of the esophagus.
(2) Complete endoscopic resection as assessed visually on Lugol chromoendoscopy immediately after EMR. (3) A diagnosis of squamous cell carcinoma on histopathological examination of the resected specimen. (4) Vertical margins of the resected specimen are confirmed to be tumor-negative. (5) Tumor invasion is limited to the mucosa on histopathological examination of the resected specimen, and no additional treatment (surgical resection, radiotherapy, chemotherapy, etc.) is performed immediately after EMR. (6) No active head or neck cancers. (7) The investigator judges that patient can be observed for at least 2 years. (8) Written informed consent is obtained from the patient. |
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Key exclusion criteria | (1) A history of chemotherapy for any other cancers or a history of surgical treatment or radiotherapy for head and neck cancers.
(2) A history of iodine allergy. (3) Patients whom the investigator considers unsuitable as subjects for this study. |
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Target sample size | 330 |
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Name of lead principal investigator |
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Organization | Kyoto University Hospital | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | 54 Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan. | ||||||
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Organization | Kitasato University Hospital | ||||||
Division name | Department of Gastroenterology | ||||||
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Address | 1-15-1 Kitasato, Sagamihara 228-8555, Japan. | ||||||
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Sponsor | |
Institute | Study Group of Japan Public Health Center |
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Funding Source | |
Organization | Japan Public Health Center |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002024 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |
2017/12/27 | JEC経過観察データ固定20171227.xls |