NCT04260139

Brief Summary

In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

February 5, 2020

Last Update Submit

November 11, 2020

Conditions

Keywords

ileocolic pediclecolon cancerStaging

Outcome Measures

Primary Outcomes (2)

  • Lymph Node Yield in Colon Cancer Resection Specimens

    Count of lymph node

    September 2019- November 2020

  • Lymph Node Yield in Colon Cancer Resection Specimens

    Involvement of lymph node

    September 2019-November 2020

Interventions

Calculation of metric variables on the colectomy specimens including Lengths as mm 1. Proximal colon, 2. Ileum in cases with right hemicolectomy only, 3. Proximal border, 4. Tumor, 5. Distal border, 6. Total specimen, 7. Vascular pedicle, the longitudinal distance between the nearest bowel wall and the end of ligated major vascular pedicle depending on the tumor's localization, 2. Colonic mesenteric area as mm2.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The pathology specimens from colon neoplasm resections will be prepared so that the lymph nodes will be separated according to their anatomic relationship to the vascular pedicles and to the tumor. Prior to dissection, the specimen will be measured from all colonic tumor patients.

You may qualify if:

  • The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colonic NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

September 1, 2019

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations