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Research on the Role of SLC1A5 in the Development of Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02633436
Recruitment Status : Unknown
Verified August 2016 by Fourth Affiliated Hospital of Guangxi Medical University.
Recruitment status was:  Recruiting
First Posted : December 17, 2015
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
Liuzhou Maternity and Child Healthcare Hospital
Information provided by (Responsible Party):
Fourth Affiliated Hospital of Guangxi Medical University

Tracking Information
First Submitted Date December 6, 2015
First Posted Date December 17, 2015
Last Update Posted Date August 12, 2016
Study Start Date December 2015
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2015)
optical density (ODs) of each slice by immunohistochemistry assay [ Time Frame: within one year (plus or minus 1 month) after surgery ]
For immunohistochemistry assay: Briefly, the samples will be cut into slices, which will be stained with standard steps. Finally, three high power fields will be randomly selected from each slice and the average optical density (OD) will be measured in each field.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02633436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2015)
SLC1A5 expression detected by WesternBlot [ Time Frame: within one year (plus or minus 1 month) after surgery ]
Western blot assay will be done by comparing the intensity of bands. To start with, xray film will be scanned on a flat-bed scanner. Then the grayscale image will be analyzed with software. Finally the Gray Value of each band will be obtained for analysis.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Research on the Role of SLC1A5 in the Development of Esophageal Cancer
Official Title Research on the Role of the Amino Acid Transporter SLC1A5 in the Development of Esophageal Cancer
Brief Summary To explore the significance of Solute Carrier Family 1 Member 5 (SLC1A5) in the occurrence of esophageal cancer, by comparing the expression of SLC1A5 between esophageal cancer tissues and adjacent tissues.
Detailed Description

This will be an observational study. The investigators will aim to enroll 100 male and female adult patients (aged 18 years and over) of all ethnicities/races, who have been referred to the Fourth Affiliated Hospital of Guangxi Medical University for esophageal cancer.

The investigators will be using a standardized data collection form. This is an observational study in which standard of care will be practiced and the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent. An attempt will be made to see if there is a correlation between the expression of SLC1A5 with esophageal cancer.

Study Type Observational
Study Design Observational Model: Case-Only
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue specimens of esophageal cancer patients will be collected and stored in liquid nitrogen after operations
Sampling Method Probability Sample
Study Population Patients with histologically proven esophageal cancer
Condition
  • Esophageal Cancer
  • Amino Acid Transport Disorder
Intervention Other: SLC1A5 expression
To observe the expression of SLC1A5 by immunohistochemistry and WesternBlot analysis.
Study Groups/Cohorts
  • cancer tissues
    SLC1A5 expression of esophageal cancer tissues from patients
    Intervention: Other: SLC1A5 expression
  • paired adjacent tissues
    SLC1A5 expression of paired adjacent esophageal tissues from patients
    Intervention: Other: SLC1A5 expression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 14, 2015)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with histologically proven esophageal cancer;
  2. Age ≥18 years;
  3. All patients must sign consent forms voluntarily;

Exclusion Criteria:

  1. Inability to obtain histologic proof of malignancy.
  2. Age <18 years;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02633436
Other Study ID Numbers PJK201518
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fourth Affiliated Hospital of Guangxi Medical University
Study Sponsor Fourth Affiliated Hospital of Guangxi Medical University
Collaborators Liuzhou Maternity and Child Healthcare Hospital
Investigators
Principal Investigator: Xiangcheng Wei Guangxi Medical University Institutional Review Board
PRS Account Fourth Affiliated Hospital of Guangxi Medical University
Verification Date August 2016