NCT03774862

Brief Summary

Medullary carcinoma (MC) is a rare tumor with solid growth pattern without glandular differentiation and constitute less than 1% of colorectal cancer. Lymph node positivity and distant organ metastasis were reported to be lower than other poorly differentiated adenocarcinomas. Therefore, the diagnosis of MC is pathologically important in terms of follow-up and treatment. MC is commonly localized in the right colon, has a large tumor size, and is mostly diagnosed in the T4 stage. As MC most likely have defects in DNA MMR, the correct pathological diagnosis is important for the postoperative treatment and the prognosis of the patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

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

January 1, 2011

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

7 years

First QC Date

September 5, 2018

Last Update Submit

December 12, 2018

Conditions

Keywords

Medullary carcinomaColorectal cancerMicrosatellite instability

Outcome Measures

Primary Outcomes (1)

  • Overall survival of medullar colorectal carcinomas

    7 years

Study Arms (2)

Medullary carcinoma of colorectal cancers

non-medullary carcinomas of the colorectal cancers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

427 patients with colorectal cancer who were underwent surgery between January 2011 and December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414) in terms of demographic characteristics, pathological data and oncological outcomes.

You may qualify if:

  • colorectal cancer diagnosis, medullary carcinoma

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, MedullaryColorectal NeoplasmsMicrosatellite Instability

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenomic InstabilityPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General surgery specialist

Study Record Dates

First Submitted

September 5, 2018

First Posted

December 13, 2018

Study Start

January 1, 2011

Primary Completion

December 31, 2017

Study Completion

August 1, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share