Surgical Outcome and Predictors of Overall Survival of St... | NCT05452382

Studies
Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma

NCT05452382

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Jul 11, 2022Actual

Enrollment

2,607Actual

Phase

Not provided

Conditions

Appendiceal Cancer

Interventions

Partial colecctomy
Hemicolectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Jul 6, 2022Actual

First Submitted Date

Jul 6, 2022

First Submission Date that Met QC Criteria

Jul 6, 2022

First Posted Date

Jul 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 11, 2022Actual

Name	Class
Cleveland Clinic Florida	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,607Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Partial colectomy		Patients with appendiceal cancer who underwent segmental resection of appendiceal adenocarcinoma	Procedure: Partial colecctomy
Hemicolectomy		Patients with appendiceal cancer who underwent formal right hemicolectomy of appendiceal adenocarcinoma	Procedure: Hemicolectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Partial colecctomy	Procedure	Segmental resection of appendiceal adenocarcinoma including terminal ileum and cecum	Partial colectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Percent of patients who were alive at five years of follow-up	60 months

Secondary Outcomes

Measure	Description	Time Frame
Positive resection margins	the rate of surgical margins infiltrated by malignancy	Immediate postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with stage I-III appendiceal adenocarcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Flroida		Weston	Florida	33331	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001063	Appendiceal Neoplasms

Ancestor Terms

ID	Term
D002430	Cecal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003082	Colectomy

Ancestor Terms

ID	Term
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided