PrognosisNCT06087887
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study
An observational study of Prognosis, run by Zhe Fan at 1 site in China.
Trial summary
The goal of this observational study is to learn about in small bowel adenocarcinoma patients. The main question it aims to answer is the association between tumor size and prognosis in patients with small bowel adenocarcinoma. Participants will be compared for the relationship between tumor size and prognosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prognosis
- How many people
- 8,163 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data of Small Bowel adenocarcinoma patients from 2004 to 2019 was collected from the SEER database using the SEER*Stat software (version 8.4.0.1).
Who may be able to join
- pathology confirmed as SBA;
- received surgery and complete postoperative follow-up data;
- histology type code 8140-8380.
Who cannot join
- Cases with unknown tumor location, size, TNM staging, race, and degree of differentiation were excluded. Finally, 8,163 eligible patients were included in the analysis
Trial locations and contacts
1 site in 1 country.
China1 site
Dalian Third People's Hospital Affiliated to Dalian Medical University
Dalian, Liaoning
About this study
The goal of this observational study is to learn about in small bowel adenocarcinoma patients. The main question it aims to answer is the association between tumor size and prognosis in patients with small bowel adenocarcinoma. Participants will be compared for the relationship between tumor size and prognosis.
- Conditions
- Prognosis
- Being tested
- no interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
no interventions
| Study group | Role | What they receive |
|---|---|---|
| tumor size 0-1cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 0-1 cm. Receives: Other: no interventions | |
| tumor size 1-2 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 1-2 cm. | |
| tumor size 2-3 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 2-3 cm. | |
| tumor size 3-4 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 3-4 cm. | |
| tumor size 4-5 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 4-5 cm. | |
| tumor size 5-6 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 5-6 cm. | |
| tumor size 6-7 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 6-7 cm. | |
| tumor size 7-8 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 7-8 cm. | |
| tumor size 8-9 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 8-9 cm. | |
| tumor size 9-10 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of 9-10 cm. | |
| tumor size >10 cm | No intervention. Select small bowel adenocarcinoma patients with tumor size of >10 cm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study
We will study the relationship between tumor size and prognosis in small bowel adenocarcinoma patients in the SEER database
Measured: 2024.9.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrognosisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 8,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhe Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhe Fan, The Third Peoples Hospital of Dalian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087887
- Sponsor's protocol ID
- ThirdPHDalian
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study
- ClinicalTrials.gov ID
- NCT06087887
- Acronym / sponsor ID
- ThirdPHDalian
- Conditions
- Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,163 participants (actual)
- Lead sponsor
- Zhe FanUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 Oct 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.
The goal of this observational study is to learn about in small bowel adenocarcinoma patients. The main question it aims to answer is the association between tumor size and prognosis in patients with small bowel adenocarcinoma. Participants will be compared for the relationship between tumor size and prognosis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| tumor size 0-1cm | – | Other: no interventionsNo intervention. Select small bowel adenocarcinoma patients with tumor size of 0-1 cm. |
| tumor size 1-2 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 1-2 cm. |
| tumor size 2-3 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 2-3 cm. |
| tumor size 3-4 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 3-4 cm. |
| tumor size 4-5 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 4-5 cm. |
| tumor size 5-6 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 5-6 cm. |
| tumor size 6-7 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 6-7 cm. |
| tumor size 7-8 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 7-8 cm. |
| tumor size 8-9 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 8-9 cm. |
| tumor size 9-10 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of 9-10 cm. |
| tumor size >10 cm | – | –No intervention. Select small bowel adenocarcinoma patients with tumor size of >10 cm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data of Small Bowel adenocarcinoma patients from 2004 to 2019 was collected from the SEER database using the SEER*Stat software (version 8.4.0.1).
Key inclusion criteria (3 listed)
- pathology confirmed as SBA;
- received surgery and complete postoperative follow-up data;
- histology type code 8140-8380.
Key exclusion criteria (1 listed)
- Cases with unknown tumor location, size, TNM staging, race, and degree of differentiation were excluded. Finally, 8,163 eligible patients were included in the analysis
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 |
|---|---|---|
| no interventionsno interventions | Other | tumor size 0-1cm |
Primary outcome
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study
Time frame: 2024.9.1
We will study the relationship between tumor size and prognosis in small bowel adenocarcinoma patients in the SEER database
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 18 Oct 2023.
- Individual participant dataSharing planned: Yes
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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 Prognosis, run by Zhe Fan 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 3 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: finished, as of the sponsor's last update on 18 Oct 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?
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study (time frame: 2024.9.1). 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 18 Oct 2023.