NCT04757311

Brief Summary

The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

August 30, 2020

Last Update Submit

October 25, 2021

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Percentage of use anti-EGFR agents

    The anti-EGFR agent selection

    throughout of treatment, 3 years

  • Progression Free Survival (PFS)

    PFS three years after initiation of treatment with anti-EGFR agents

    3 years treatment

Secondary Outcomes (1)

  • Advers events

    throughout of treatment, 3 years

Other Outcomes (1)

  • Percentage of use biologics in right side tumors.

    throughout of treatment, 3 years

Study Arms (1)

Metastatic Colorectal Cancer Patients

All RAS wild type metastatic colorectal cancer patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed within 3-years period before March 2019 will be included.

You may qualify if:

  • Patients who have been histologically diagnosed with mCRC
  • Patients over the age of 18
  • Patients receiving at least a cycle systemic treatment for metastatic disease
  • RAS wild type patients
  • Patients who has demographic, histopathological and clinical information

You may not qualify if:

  • Patients diagnosed as mCRC but only referred to BSC
  • Patients with RAS mutation
  • Patients who were included in any clinical trial except standard treatments during their treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Hospital

Istanbul, 81450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahmut Gumus, MD, Professor Medical Oncolgy

Study Record Dates

First Submitted

August 30, 2020

First Posted

February 17, 2021

Study Start

August 1, 2020

Primary Completion

April 30, 2021

Study Completion

October 1, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)