Effects of gene expression pattern and RAS/BRAF mutations on the course of colorectal cancer
| ISRCTN | ISRCTN18093312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18093312 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/10/2015
- Registration date
- 20/10/2015
- Last edited
- 18/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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)
Contact information
Scientific
FGBU "State scientific centre of coloproctology" Ministry of Health of Russia
2, Salyama Adilya str.
Moscow
123423
Russian Federation
 ORCID ID |
0000-0001-5255-5065 |
|---|
Scientific
FGBU "State scientific centre of coloproctology" Ministry of Health of Russia
2, Salyama Adilya str.
Moscow
123423
Russian Federation
| ORCID ID |
0000-0001-8571-7462 |
|---|
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The gene expression pattern and RAS/BRAF mutation status of tumor as a prognostic factor for colorectal cancer |
| Study objectives | 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(s) | FGBU "State scientific centre of coloproctology" Ministry of Health of Russia Ethics Committee №27, 13/10/2015 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Disease-free survival (DFS) |
| Secondary outcome measures | 1. Overall survival (OS) 2. Time to relapse (TTR) |
| Overall study start date | 01/11/2015 |
| Completion date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | Potentially curable colorectal cancer |
| Key exclusion criteria | 1. Participants that have had preoperative chemotherapy and/or radiotherapy 2. Patient that refuse to follow the study protocol |
| Date of first enrolment | 01/11/2015 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Moscow
123423
Russian Federation
Sponsor information
Research organisation
2, Salyama Adilya str.
Moscow
123423
Russian Federation
| Website | http://www.gnck.ru/ |
|---|---|
"ROR" |
https://ror.org/04rbazs75 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | We are planning to publish preliminary results of the investigation in one of the BioMed Central journals in 2017. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/06/2018 | Yes | No |
Editorial Notes
18/02/2019: Publication reference added.
