Prognosis of Patients With ESCCESCCNCT03831828
Correlation of Gene Status and Clinical Outcomes in ESCC
An observational study of Prognosis of Patients With ESCC, run by LiuJunFeng at 1 site in China.
Trial summary
The incidence of esophageal squamous cell carcinoma is highly regional and familial. The current treatment plan is based on the stage and location of the tumor.By studying the relationship between the status of different genes and prognosis, it can help doctors to develop precise and individualized treatment plans. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Prognosis of Patients With ESCC
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2018to 1 Apr 2019
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Taihang Mountain area population in northern China.
Who may be able to join
- Esophageal cancer patients who underwent surgery treatment, and postoperative pathological diagnosis was squamous cell carcinoma. Patients with ESCC have complete clinical information.
Who cannot join
- Patients who also suffering from other tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junfeng Liu
Shijiazhuang, Hebei, 050000
Junfeng Liu, Professor, 13931152296, 13931152296@126.com
About this study
Official title: Retrospective Study of Gene Status and Clinical Outcome of Esophageal Squamous Cell Carcinoma(ESCC).
The incidence of esophageal squamous cell carcinoma is highly regional and familial. The current treatment plan is based on the stage and location of the tumor.By studying the relationship between the status of different genes and prognosis, it can help doctors to develop precise and individualized treatment plans.
- Conditions
- Prognosis of Patients With ESCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lymph node metastasis Positive | good prognosis; without Lymph node metastasis. | |
| Lymph node metastasis Negative | poor prognosis; with Lymph node metastasis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene test
466 Tumor-associated gene test by next-generation sequencing(NGS)
Measured: 2019-2 to 2019-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start26 Dec 2018
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prognosis of Patients With ESCCStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiuJunFeng
- Sponsor type
- University, hospital or other
- Collaborators
- OrigiMed
- Responsible party
- Sponsor-investigator, LiuJunFeng, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831828
- Sponsor's protocol ID
- HebeiMUFH-ESCC
- Acronym
- ESCC
- Status last verified
- Sep 2018
- First submitted
- 4 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Gene Status and Clinical Outcome of Esophageal Squamous Cell Carcinoma(ESCC).
- ClinicalTrials.gov ID
- NCT03831828
- Acronym / sponsor ID
- ESCC / HebeiMUFH-ESCC
- Conditions
- Prognosis of Patients With ESCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- LiuJunFengUniversity, hospital or other
- Collaborators
- OrigiMed
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 6 Feb 2019 (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 incidence of esophageal squamous cell carcinoma is highly regional and familial. The current treatment plan is based on the stage and location of the tumor.By studying the relationship between the status of different genes and prognosis, it can help doctors to develop precise and individualized treatment plans.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymph node metastasis Positive | – | –good prognosis; without Lymph node metastasis. |
| Lymph node metastasis Negative | – | –poor prognosis; with Lymph node metastasis. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Taihang Mountain area population in northern China.
Key inclusion criteria (1 listed)
- Esophageal cancer patients who underwent surgery treatment, and postoperative pathological diagnosis was squamous cell carcinoma. Patients with ESCC have complete clinical information.
Key exclusion criteria (1 listed)
- Patients who also suffering from other tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene test
Time frame: 2019-2 to 2019-4
466 Tumor-associated gene test by next-generation sequencing(NGS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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.
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 Prognosis of Patients With ESCC, run by LiuJunFeng 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 1 inclusion and 1 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 8 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junfeng Liu, MD (13931152296, 13931152296@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene test (time frame: 2019-2 to 2019-4). 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 8 Feb 2019.