Metastatic Colorectal Cancer. Real-World Data Analysis. | NCT04757311

Studies
Metastatic Colorectal Cancer. Real-World Data Analysis.

NCT04757311

Sponsor

Istanbul Medeniyet University

Status

Completed

Last Update Posted

Oct 27, 2021Actual

Enrollment

1,750Actual

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Oct 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

Aug 1, 2020Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Aug 30, 2020

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 17, 2021Actual

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

Oct 25, 2021

Last Update Posted Date

Oct 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmut Gumus, Mahmut Gumus, MD, Professor Medical Oncolgy, Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

Collaborators

Not provided

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

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

Detailed Description

In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.

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

1,750Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metastatic Colorectal Cancer Patients		All RAS wild type metastatic colorectal cancer patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Advers events	Advers event of anti EGFR is defined as any untoward or unfavourable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with the patient's participation. The CTCAE v.4.0 will use in this research.	throughout of treatment, 3 years

Other Outcomes

Measure	Description	Time Frame
Percentage of use biologics in right side tumors.	Treatment selection in right side tumors.	throughout of treatment, 3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medeniyet University Hospital		Istanbul		81450	Turkey (Türkiye)

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
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided