Medullary Colonic Carcinoma | NCT05184153

Studies
Medullary Colonic Carcinoma

NCT05184153

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Medullary Carcinoma of Colon
Prognostic Factors
Survival Analysis

Interventions

Not provided

Countries

France

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

Sep 2021

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

Mar 3, 2020Actual

Primary Completion Date

Dec 19, 2020Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Oct 28, 2021

First Submission Date that Met QC Criteria

Jan 7, 2022

First Posted Date

Jan 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

Jan 7, 2022

Last Update Posted Date

Jan 11, 2022Actual

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

Retrospective cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. Collection of relevant data for this rare entity. Subgroup analysis in search of prognostic factors. Comparison of the data from our cohort with those from the literature.

Detailed Description

Colorectal cancer (CRC) is the third most common cancer in the world after breast and prostate cancer (1). It is also the second most common cause of cancer death in France (2). Most CRCs are adenocarcinomas. However, there is a distinct subtype of adenocarcinoma of relatively recent recognition, called medullary carcinomas (MC). Its recent recognition as a distinct entity (3) has made it difficult to study the epidemiologic characteristics of this cancer, with little population-based data. The largest cohort studied in the literature is from a US sample of 74 patients seen between 1973 and 2006 (4). The main objective of this French retrospective study is to highlight some common features in this group of patients with medullary colorectal cancers, thus improving our knowledge of this cancer subtype and in particular its prognosis.

Medullary colorectal cancer is a type of cancer with a prognosis of its own, probably different from the most common histological entity, colorectal adenocarcinoma.

This is a retrospective study a cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. A collection of relevant data was realised for the subgroup analysis in search of prognostic factors for this rare entity as well as a comparison of the data from this cohort with those from the literature.

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

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Number of days between diagnosis and death	Through study completion in April 2021

Secondary Outcomes

Measure	Description	Time Frame
Progression	Number of days between first surgery and appearance of metastases	Through study completion in April 2021

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathological diagnosis of colorectal adenocarcinoma of medullary type between 2000 and 2020

Exclusion Criteria:

Absence of anatomopathological confirmation on the surgical specimen

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

All patients with an anatomopathological diagnosis of colorectal adenocarcinoma of medullary type managed at the chu de Limoges between 2000 and 2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Niki CHRISTOU, Dr	0 33 5 55 05 67 30	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Digestive et Endocrinienne du CHU de Limoges		Limoges		87045	France