Esophageal CancerNCT02633436
Research on the Role of SLC1A5 in the Development of Esophageal Cancer
An observational study of Esophageal Cancer and Amino Acid Transport Disorder, run by Fourth Affiliated Hospital of Guangxi Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Amino Acid Transport Disorder
- What is being tested?
- SLC1A5 expression
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2015to Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically proven esophageal cancer
Who may be able to join
- Patients with histologically proven esophageal cancer;
- Age ≥18 years;
- All patients must sign consent forms voluntarily;
Who cannot join
- Inability to obtain histologic proof of malignancy.
- Age <18 years;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Liuzhou Maternity and Child Healthcare Hospital
Liuzhou, Guangxi, 545000
Xiaolan Lv, +86 15577727711, 13505525@qq.com
- Recruiting
The Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, 545000
Zheng Peng, +86 18589966550, labstar@qq.com
About this study
Official title: Research on the Role of the Amino Acid Transporter SLC1A5 in the Development of Esophageal Cancer
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.
Read the 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.
- Conditions
- Esophageal Cancer, Amino Acid Transport Disorder
- Being tested
- SLC1A5 expression
- Keywords
- esophageal cancer, SLC1A5
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLC1A5 expressionOther
To observe the expression of SLC1A5 by immunohistochemistry and WesternBlot analysis.
| Study group | Role | What they receive |
|---|---|---|
| cancer tissues | SLC1A5 expression of esophageal cancer tissues from patients Receives: Other: SLC1A5 expression | |
| paired adjacent tissues | SLC1A5 expression of paired adjacent esophageal tissues from patients Receives: Other: SLC1A5 expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
optical density (ODs) of each slice by immunohistochemistry assay
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.
Measured: within one year (plus or minus 1 month) after surgery
Secondary outcomes (1)
SLC1A5 expression detected by WesternBlot
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.
Measured: within one year (plus or minus 1 month) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 only
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital
- Responsible party
- Sponsor
- Investigators
- Xiangcheng Wei, Principal investigator, Guangxi Medical University Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633436
- Sponsor's protocol ID
- PJK201518
- Status last verified
- Aug 2016
- First submitted
- 6 Dec 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Role of the Amino Acid Transporter SLC1A5 in the Development of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02633436
- Acronym / sponsor ID
- PJK201518
- Conditions
- Esophageal Cancer, Amino Acid Transport Disorder
- Keywords
- esophageal cancer, SLC1A5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital
- Study start
- Dec 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- 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.
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 design
- Observational model
- Case only
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer tissues | – | Other: SLC1A5 expressionSLC1A5 expression of esophageal cancer tissues from patients |
| paired adjacent tissues | – | Other: SLC1A5 expressionSLC1A5 expression of paired adjacent esophageal tissues from patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven esophageal cancer
Key inclusion criteria (3 listed)
- Patients with histologically proven esophageal cancer;
- Age ≥18 years;
- All patients must sign consent forms voluntarily;
Key exclusion criteria (2 listed)
- Inability to obtain histologic proof of malignancy.
- Age <18 years;
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 |
|---|---|---|
| SLC1A5 expressionTo observe the expression of SLC1A5 by immunohistochemistry and WesternBlot analysis. | Other | cancer tissues, paired adjacent tissues |
Primary outcome
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.
1 secondary outcome
SLC1A5 expression detected by WesternBlot
Time frame: within one year (plus or minus 1 month) after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Xiangcheng Wei principal investigator
Guangxi Medical University Institutional Review Board
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Amino Acid Transport Disorder, run by Fourth Affiliated Hospital of Guangxi Medical University at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengming Dai, Dr. (+86 13978026884, daishm@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optical density (ODs) of each slice by immunohistochemistry assay (time frame: within one year (plus or minus 1 month) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2016.