Condition category
Cancer
Date applied
19/10/2015
Date assigned
20/10/2015
Last edited
22/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Colorectal cancer, otherwise known as bowel cancer, is a disease where cancerous tumors develop in the large bowel (colon cancer) and cancer of the back passage (rectal cancer). Currently, histological characteristics of the tumor (i.e. its structure) and whether there are mutations to the KRAS or BRAF genes are used to predict the likely clinical course of colorectal cancer (i.e. the prognosis). Analysis of the expression profile of the tumor (a test that identifies which genes have been mutated) can increase the prognostic significance of molecular characteristics (distinguishing features of the individual cancer cells) for colorectal cancer. The aim of this study is to find out how well this new technology can help in the prognosis of this disease.

Who can participate?
Adults with potentially curable colorectal cancer that have not had chemotherapy and/or radiotherapy before surgery.

What does the study involve?
Tumors that have been removed from patients though surgery have their expression profile analysed. After this analysis, they are assigned to one of five different subtypes, including, stem-like, inflammatory, transit-amplifying, goblet-like and enterocyte. Patients with stage 1 cancer are then followed up three years after the surgery. Patients with stage III-IV are treated with chemotherapy according to common oncological practice. Patients with stage II receive either chemotherapy or not depending upon the decision of a chemotherapist. Follow up for all patients in the study is 3 years after surgery to see how long they survived disease free, how long it took them to relapse (if they did so) and how long did they survive for after surgery.

What are the possible benefits and risks of participating?
There are no risks to participating.

Where is the study run from?
FGBU "State scientific centre of coloproctology" Ministry of Health of Russia

When is the study starting and how long is it expected to run for?
November 2015 to October 2021

Who is funding the study?
Ministry of Health of Russia

Who is the main contact?
1. Dr. Natalia Pospekhova (scientific)
2. Dr. Alexei Tsukanov (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Natalia Pospekhova

ORCID ID

http://orcid.org/0000-0001-5255-5065

Contact details

FGBU "State scientific centre of coloproctology" Ministry of Health of Russia
2
Salyama Adilya str.
Moscow
123423
Russian Federation

Type

Scientific

Additional contact

Dr Alexei Tsukanov

ORCID ID

http://orcid.org/0000-0001-8571-7462

Contact details

FGBU "State scientific centre of coloproctology" Ministry of Health of Russia
2
Salyama Adilya str.
Moscow
123423
Russian Federation

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The gene expression pattern and RAS/BRAF mutation status of tumor as a prognostic factor for colorectal cancer

Acronym

Study hypothesis

The study hypothesis is based on the idea that the gene expression profile and RAS/BRAF status of the tumor can be prognostic factors of the clinical course of colorectal cancer disease

Ethics approval

FGBU "State scientific centre of coloproctology" Ministry of Health of Russia Ethics Committee №27, 13/10/2015

Study design

Prospective cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Colorectal cancer

Intervention

Tumors of operated patients will be assessed for expression profile and somatic KRAS/BRAF mutations. All cases will be then assigned to one of five different subtypes, as described Sadanandam and co-authors in 2013 (doi:10.1038/nm.3175):
1. Stem-like
2. Inflammatory
3. Transit-amplifying
4. Goblet-like
5. Enterocyte
Patients with stage I will undergo follow up only. Patients with stage III-IV will be treated with chemotherapy according to common oncological practice. Patients with stage II will either receive chemotherapy or not on dessision of chemotherapist.

Follow up for all patients in the study is 3 years after surgery.

Intervention type

Genetic

Phase

Drug names

Primary outcome measures

Disease-free survival (DFS)

Secondary outcome measures

1. Overall survival (OS)
2. Time to relapse (TTR)

Overall trial start date

01/11/2015

Overall trial end date

31/10/2021

Reason abandoned

Eligibility

Participant inclusion criteria

Potentially curable colorectal cancer

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Participants that have had preoperative chemotherapy and/or radiotherapy
2. Patient that refuse to follow the study protocol

Recruitment start date

01/11/2015

Recruitment end date

31/10/2021

Locations

Countries of recruitment

Russian Federation

Trial participating centre

FGBU "State scientific centre of coloproctology" Ministry of Health of Russia
2, Salyama Adilya str.
Moscow
123423
Russian Federation

Sponsor information

Organisation

FGBU "State scientific centre of coloproctology" Ministry of Health of Russia

Sponsor details

2
Salyama Adilya str.
Moscow
123423
Russian Federation

Sponsor type

Research organisation

Website

http://www.gnck.ru/

Funders

Funder type

Research organisation

Funder name

FGBU "State scientific centre of coloproctology" Ministry of Health of Russia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are planning to publish preliminary results of the investigation in one of the BioMed Central journals in 2017.

Intention to publish date

01/06/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes