SurvivorshipOSmodelNCT06169930
Development and Validation of a Survival Prediction Model for Esophageal Cancer Patients After Esophagectomy
An observational study of Survivorship, run by Yongtao Han at 1 site in China.
Trial summary
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Survivorship
- What is being tested?
- This was an observational study without any intervention
- How many people
- 2,957 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2023
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017.
Who may be able to join
- Patients underwent esophagectomy at our hospital.
Who cannot join
- pathology confirmed a non-squamous cell carcinoma,
- the tumor was located outside of the thoracic region,
- R1/R2 resection was performed indicating incomplete tumor removal,
- evidence of distant tumor metastasis was observed, or
- they underwent preoperative neoadjuvant therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
About this study
Official title: Development and Validation of A Overall Survival Prediction Model for Esophageal Squamous Cell Carcinoma: A Novel pN Classification
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017. Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy. Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables.
Read the detailed description
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017. Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy. Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables. Additionally, the receiver operating characteristic curve demonstrated an area under the curve greater than 0.7 at 1, 3, and 5 years in both the verification and training groups. Furthermore, Kaplan-Meier (K-M) curves showed that our model effectively distinguished between high- and low-risk groups (p < 0.01).
- Conditions
- Survivorship
- Being tested
- This was an observational study without any intervention
- Keywords
- survival, esophgeal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This was an observational study without any interventionOther
This was an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| high-risk | Not described Receives: Other: This was an observational study without any intervention | |
| low-risk | Not described Receives: Other: This was an observational study without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall survival (OS) was defined as the time from the month and year of surgery until death or the last follow-up in April 2022.
Measured: April 2022-April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies 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
- 2,957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongtao Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Han, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169930
- Sponsor's protocol ID
- SCCH-TS2207
- Acronym
- OSmodel
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of A Overall Survival Prediction Model for Esophageal Squamous Cell Carcinoma: A Novel pN Classification
- ClinicalTrials.gov ID
- NCT06169930
- Acronym / sponsor ID
- OSmodel / SCCH-TS2207
- Conditions
- Survivorship
- Keywords
- survival, esophgeal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,957 participants (actual)
- Lead sponsor
- Yongtao HanUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Dec 2023 (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.
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017. Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy. Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables.
Detailed description
In this retrospective study, we analyzed data from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017. Our study focused on examining the clinicopathological characteristics, lymph node removal at each station, and treatment details of patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy. Using this data, we developed a prediction model for OS by considering a combination of clinical characteristics and details of lymphadenectomy variables. Additionally, the receiver operating characteristic curve demonstrated an area under the curve greater than 0.7 at 1, 3, and 5 years in both the verification and training groups. Furthermore, Kaplan-Meier (K-M) curves showed that our model effectively distinguished between high- and low-risk groups (p < 0.01).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-risk | – | Other: This was an observational study without any intervention |
| low-risk | – | Other: This was an observational study without any intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management Database (SCH-ECCM Database) from January 2010 to December 2017.
Key inclusion criteria (1 listed)
- Patients underwent esophagectomy at our hospital.
Key exclusion criteria (5 listed)
- pathology confirmed a non-squamous cell carcinoma,
- the tumor was located outside of the thoracic region,
- R1/R2 resection was performed indicating incomplete tumor removal,
- evidence of distant tumor metastasis was observed, or
- they underwent preoperative neoadjuvant therapy
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 |
|---|---|---|
| This was an observational study without any interventionThis was an observational study without any intervention | Other | high-risk, low-risk |
Primary outcome
Survival
Time frame: April 2022-April 2024
Overall survival (OS) was defined as the time from the month and year of surgery until death or the last follow-up in April 2022.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Survivorship, run by Yongtao Han 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 5 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: finished, as of the sponsor's last update on 14 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: April 2022-April 2024). 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 14 Dec 2023.