Appendiceal CancerNCT05452382
Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma
An observational study of Appendiceal Cancer, run by Mansoura University at 1 site in United States.
Trial summary
A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendiceal Cancer
- What is being tested?
- Partial colecctomy and Hemicolectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,607 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2005to 6 Jul 2022
- 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: Patients with stage I-III appendiceal adenocarcinoma
Who may be able to join
- patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection
Who cannot join
- Patients with other pathologic types of appendiceal cancer
- Patients with clinical stage IV or unknown stage
- Patients who did not undergo surgery, underwent local excision, or had unknown/non-specified surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma; a National Cancer Database Analysis
A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Another small single-center study including 49 appendiceal cancer patients reported female gender and low-grade adenocarcinoma to be associated with increased overall survival. However, these previous analyses did not take into account some important prognosticators of survival such as patients' comorbidities and functional status, pathologic parameters such as lymphovascular invasion, and adjuvant systemic treatment. Therefore, we used the National Cancer Database (NCDB) to conduct a comprehensive analysis of the predictors of overall survival after surgical treatment of stage I-III appendiceal adenocarcinoma.
- Conditions
- Appendiceal Cancer
- Being tested
- Partial colecctomy, Hemicolectomy
- Medical subject headings
- Appendiceal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial colecctomyProcedure or surgery
Segmental resection of appendiceal adenocarcinoma including terminal ileum and cecum
HemicolectomyProcedure or surgery
Formal right hemicolectomy including terminal ileum, cecum, and ascending colon
| Study group | Role | What they receive |
|---|---|---|
| Partial colectomy | Patients with appendiceal cancer who underwent segmental resection of appendiceal adenocarcinoma Receives: Procedure: Partial colecctomy | |
| Hemicolectomy | Patients with appendiceal cancer who underwent formal right hemicolectomy of appendiceal adenocarcinoma Receives: Procedure: Hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Percent of patients who were alive at five years of follow-up
Measured: 60 months
Secondary outcomes (1)
Positive resection margins
the rate of surgical margins infiltrated by malignancy
Measured: Immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jan 2005
- Primary completion30 Dec 2019
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendiceal CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 2,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Cleveland Clinic Florida
- Responsible party
- Principal investigator, Sameh Emile, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452382
- Sponsor's protocol ID
- NCDBAppendix
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma; a National Cancer Database Analysis
- ClinicalTrials.gov ID
- NCT05452382
- Acronym / sponsor ID
- NCDBAppendix
- Conditions
- Appendiceal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,607 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Cleveland Clinic Florida
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 11 Jul 2022 (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.
A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Another small single-center study including 49 appendiceal cancer patients reported female gender and low-grade adenocarcinoma to be associated with increased overall survival. However, these previous analyses did not take into account some important prognosticators of survival such as patients' comorbidities and functional status, pathologic parameters such as lymphovascular invasion, and adjuvant systemic treatment. Therefore, we used the National Cancer Database (NCDB) to conduct a comprehensive analysis of the predictors of overall survival after surgical treatment of stage I-III appendiceal adenocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial colectomy | – | Procedure: Partial colecctomyPatients with appendiceal cancer who underwent segmental resection of appendiceal adenocarcinoma |
| Hemicolectomy | – | Procedure: HemicolectomyPatients with appendiceal cancer who underwent formal right hemicolectomy of appendiceal adenocarcinoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage I-III appendiceal adenocarcinoma
Key inclusion criteria (1 listed)
- patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection
Key exclusion criteria (3 listed)
- Patients with other pathologic types of appendiceal cancer
- Patients with clinical stage IV or unknown stage
- Patients who did not undergo surgery, underwent local excision, or had unknown/non-specified surgery
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 |
|---|---|---|
| Partial colecctomySegmental resection of appendiceal adenocarcinoma including terminal ileum and cecum | Procedure or surgery | Partial colectomy |
| HemicolectomyFormal right hemicolectomy including terminal ileum, cecum, and ascending colon | Procedure or surgery | Hemicolectomy |
Primary outcome
Overall survival
Time frame: 60 months
Percent of patients who were alive at five years of follow-up
1 secondary outcome
Positive resection margins
Time frame: Immediate postoperative
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 11 Jul 2022.
- 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 Appendiceal Cancer, run by Mansoura University at 1 site in United States.
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 3 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 11 Jul 2022. 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 United States. 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?
Overall survival (time frame: 60 months). 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 11 Jul 2022.