Rectal NeoplasmsNCT06143605
Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors
An observational study of Rectal Neoplasms and Neuroendocrine Tumors, run by Yanhong Deng.
Trial summary
we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rectal Neoplasms, Neuroendocrine Tumors
- What is being tested?
- salvage treatment
- Type of treatment
- Surgery or procedure
- How many people
- 527 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2013to 30 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with rectal neuroendocrine tumors following initial endoscopic resection
Who may be able to join
- within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge.
Who cannot join
- (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.
About this study
Official title: Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study
we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.
- Conditions
- Rectal Neoplasms, Neuroendocrine Tumors
- Being tested
- salvage treatment
- Keywords
- endoscopic resection
- Medical subject headings
- Rectal Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salvage treatmentProcedure or surgery
salvage radical surgery or endoscopic resection
| Study group | Role | What they receive |
|---|---|---|
| salvage treatment group | patients with salvage treatment after endoscopic resection were diagnosed as having positive resection margin status Receives: Procedure: salvage treatment | |
| without salvage treatment group | patients without salvage treatment after endoscopic resection were diagnosed as having positive resection margin status |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease free survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start30 Jan 2013
- Primary completion30 Dec 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanhong Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143605
- Sponsor's protocol ID
- GIH-SYip33
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study
- ClinicalTrials.gov ID
- NCT06143605
- Acronym / sponsor ID
- GIH-SYip33
- Conditions
- Rectal Neoplasms, Neuroendocrine Tumors
- Keywords
- endoscopic resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Yanhong DengUniversity, hospital or other
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Nov 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.
we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salvage treatment group | – | Procedure: salvage treatmentpatients with salvage treatment after endoscopic resection were diagnosed as having positive resection margin status |
| without salvage treatment group | – | –patients without salvage treatment after endoscopic resection were diagnosed as having positive resection margin status |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with rectal neuroendocrine tumors following initial endoscopic resection
Key inclusion criteria (1 listed)
- within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge.
Key exclusion criteria (1 listed)
- (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.
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 |
|---|---|---|
| salvage treatmentsalvage radical surgery or endoscopic resection | Procedure or surgery | salvage treatment group |
Primary outcome
DFS
Time frame: 5 year
disease free survival
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 22 Nov 2023.
- Individual participant dataSharing planned: No. available upon reasonable request
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms and Neuroendocrine Tumors, run by Yanhong Deng.
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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
DFS (time frame: 5 year). 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 22 Nov 2023.