- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416101
Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival (SiewertIIEAC)
January 23, 2018 updated by: Sandro Mattioli, University of Bologna
Siewert Type II Esophageal Adenocarcinoma: on the Relationship Between Histology, Esophageal-gastric Intestinal Metaplasia and Gastric Greater Curvature Lymphatic Metastases, Survival
In Siewert type II adenocarcinoma, the relationship between adenocarcinoma sub types and survival, histologic/biologic patterns related to the presence/absence of gastric greater curvature metastases, were investigated.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In order to achieve further data on the biological patterns of intestinal and diffuse subtypes of esophageal adenocarcinoma (Lauren's classification), on the frequency of gastric greater curvature nodal stations and on the clinical relevance, in terms of prognosis and survival, of these parameters, a Siewert type II case series of Siewert type II adenocarcinomas, submitted to primary (no neoadjuvant therapy) surgical, studied, operated upon and followed up, were analysed.
According to histologic patterns, cases were ordered in intestinal and diffuse adenocarcinoma sub types (Lauren's classification)and distinguished in Barret's, cardiopyloric, gastric types.
Study Type
Observational
Enrollment (Actual)
154
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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BO
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Bologna, BO, Italy, 40138
- Sandro Mattioli - Alma Mater Studiorum-University
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Bo
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Bologna, Bo, Italy, 40138
- Department of Medical And Surgical Sciences University of Bologna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
One hundred fifty four Siewert type II cases were enrolled: 124 men (80.5%), 30 women (19.5%), median age 65.5 (interquartile range 58-71); Intestinal type 91 (59%) and Diffuse type 63 (41%).
Description
Inclusion Criteria:
Siewert type II adenocarcinoma > 18 year submitted to primary surgery
Exclusion Criteria: Siewert type II adenocarcinoma submitted to neoadjuvant therapy.
Siewert type I adenocarcinoma. Siewert type III adenocarcinoma Squamous Carcinoma
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: 5 years
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5 year survival between intestinal and diffuse types (Lauren's classification) of Siewert type II adenocarcinoma after primary surgery,
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of gastric greater curvature lymph nodes metastases in Siewert II adenocarcinoma
Time Frame: 5 years
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Frequency of gastric greater curvature lymph nodes metastases and survival
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandro Mattioli - Alma M Studiorum-University, MD, Department of Medical and Surgical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2007
Primary Completion (Actual)
June 30, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
January 23, 2018
First Submitted That Met QC Criteria
January 23, 2018
First Posted (Actual)
January 30, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADECC_2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Siewert Type II Adenocarcinoma of Esophagogastric Junction
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St. James's Hospital, IrelandUnknownBarrett Esophagus | Siewert Type II Adenocarcinoma of Esophagogastric Junction | Oesophagus Cancer | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionIreland
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Jennifer Eva SelfridgeNot yet recruitingSiewert Type II Adenocarcinoma of Esophagogastric Junction | Adenocarcinoma Esophagus | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Locally Advanced Adenocarcinoma
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Guangdong Provincial Hospital of Traditional Chinese...RecruitingSiewert Type II Adenocarcinoma of Esophagogastric Junction | Esophagogastric Junction AdenocarcinomaChina
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West China HospitalRecruitingRecurrence | Stomach Neoplasms | Siewert Type II Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionChina
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of...Not yet recruitingEsophageal Cancer | Oesophageal Cancer | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionRussian Federation
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AIO-Studien-gGmbHNeovii BiotechCompletedGastric Adenocarcinoma With Peritoneal Carcinomatosis | Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis | Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal CarcinomatosisGermany
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Xijing Hospital of Digestive DiseasesFirst Affiliated Hospital Xi'an Jiaotong University; Henan Provincial People... and other collaboratorsRecruitingSiewert Type II Adenocarcinoma of Esophagogastric JunctionChina
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Northern Jiangsu People's HospitalCompletedAnti-Reflux Alimentary Reconstruction | Laparoscopic Proximal Gastrectomy | Siewert Type II/III Adenocarcinoma of the Esophagogastric JunctionChina
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of...Not yet recruitingStomach Cancer | Gastric Cancer | Siewert Type III Adenocarcinoma of Esophagogastric JunctionRussian Federation
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Technical University of MunichCompletedAdenocarcinoma of the Esophagogastric JunctionGermany
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The First Affiliated Hospital with Nanjing Medical...Not yet recruiting
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Fujian Medical UniversityRecruitingRobotic Surgery | Stomach NeoplasmChina
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Fujian Medical UniversityEnrolling by invitation
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Chinese PLA General HospitalUnknown
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Guangdong Provincial Hospital of Traditional Chinese...UnknownGastric Cancer | Splenic Hilum Lymph Nodes Dissection | Total GastrectomyChina
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Fudan UniversityUnknownAdenocarcinoma of Esophagogastric Junction.China
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Fudan UniversityRecruiting
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Seoul National University Bundang HospitalCompletedGastric CancerKorea, Republic of
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Shanghai Zhongshan HospitalCompleted