Intestinal cancer and the risk for other cancer in the same person
| ISRCTN | ISRCTN11642464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11642464 |
- Submission date
- 11/06/2023
- Registration date
- 16/06/2023
- Last edited
- 15/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Disparities between tumors arising via different carcinogenetic pathways have not been studied systematically. This study evaluated the differences in the risk for non-intestinal cancer between patients with intestinal cancer originating from different carcinogenetic statuses.
Who can participate?
Adult patients with histologically confirmed colorectal cancer
What does this study involve?
This is a retrospective cohort study describing the association between intestinal and not intestinal cancer among patients with different carcinogenetic backgrounds. This retrospective European multicenter cohort study included 1706 CRC patients treated between 1986 and 2019, in three different countries.
What are the possible benefits and risks of participating?
The possible benefit is to understand the relationship between different types of cancer in the same patient. There are no risks for participants.
Where is the study run from?
Umeå University (Sweden)
When is the study starting and how long is it expected to run for?
January 2013 to March 2021
Who is funding the study?
1. Faculty of Medicine at Umeå University
2. Cancer Foundation Finland
3. Cancer Research Foundation in Northern Sweden
4. Nordic Cancer Union
5. The Northern Healthcare Regional Association
Who is the main contact?
Ioannis Gkekas (Senior Consultant Surgeon), ioannis.gkekas@umu.se (Sweden)
Contact information
Principal Investigator
Hoppets Gränd 8
Umeå
90334
Sweden
 ORCID ID |
0000-0002-7382-3636 |
|---|---|
| Phone | +46703660249 |
| gkekasioannis@windowslive.com |
Scientific
Umeå University
Faculty of medicine
Department of Surgical and Perioperative Science, Surgery
Kungsgatan 81
Umeå
903 30
Sweden
| ORCID ID |
0000-0002-3806-2114 |
|---|---|
| Phone | +46706320353 |
| ulf.gunnarsson@umu.se |
Public
Umeå University
Faculty of medicine
Department of Surgical and Perioperative Science, Surgery
Kungsgatan 81
Umeå
903 30
Sweden
| ORCID ID |
0000-0001-5838-9133 |
|---|---|
| Phone | 0046733820772 |
| karin.strigard@umu.se |
Study information
| Study design | Multicenter retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Laboratory, Medical and other records |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Sporadic deficient mismatch repair in colorectal cancer increases the risk for non-colorectal malignancy |
| Study acronym | registerMMR |
| Study hypothesis | A higher association between sporadic deficient mismatch repair (dMMR) status and the risk of non-colorectal malignancy in patients with known colorectal cancer (CRC) |
| Ethics approval(s) |
Approved 02/12/2014, Regional Medical Review Board in Umeå, Department of Medical Strengthening (Regional etikprövningsnämnden i Umeå Avdelningen fur Medicinsk Forstkning) (Samverkanshuset, C/o Umeå Universitet, Umeå, 90187, Sweden; +46 (0)104750800; registrator@etikprovning.se), ref: 2014-371-31M |
| Condition | Association between sporadic dMMR status and the risk of non-colorectal malignancy in patients with known colorectal cancer |
| Intervention | This study is a retrospective cohort describing the association between intestinal and not intestinal cancer among patients with different carcinogenetic backgrounds. This retrospective European multicenter cohort study included 1706 CRC patients treated between 1986 and 2019, in three different countries. The proficiency (pMMR) or deficiency (dMMR) of mismatch repair was determined by immunohistochemistry. Cases were analyzed for BRAFV600E mutation, and BRAF mutation cases were further analyzed for hypermethylation status in the promotor region of MLH1 in order to distinguish between sporadic and hereditary cases. Scandinavian patients were matched against their respective National Cancer Registries. Thorough scrutiny of medical files was performed for the Czech cohort to identify any non-colorectal malignancy within 20 years prior to or after the diagnosis of CRC. Poisson regression analysis was performed to identify the incidence rate of non-colorectal malignancy. For validation purposes, standardized incidence ratios (SIR) were calculated for each cancer reported, adjusted for age, year, and sex. |
| Intervention type | Other |
| Primary outcome measure | The risk for non-colorectal malignancy before and after this diagnosis, compared to patients with different MMR tumors is measured using Incidence Rate Ratio (IRR) in both the univariable and multivariable analyses at one timepoint |
| Secondary outcome measures | Standardized incidence ratios (SIR) are calculated for each of the cancer forms reported (patients with pMMR and dMMR separately) and adjusted for sex, year (in one-year classes), and age (in five-year classes) at one timepoint |
| Overall study start date | 01/01/2013 |
| Overall study end date | 02/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 2107 |
| Total final enrolment | 1706 |
| Participant inclusion criteria | 1. Histologically confirmed CRC 2. Stage confirmed and transformed to the American Joint Committee on Cancer (AJCC) TNM classification 3. Available clinical and pathological data regarding the course of the disease and demographic data |
| Participant exclusion criteria | 1. Patients younger than 18 years 2. Inconclusive immunohistochemical analysis (IHC) or missing data |
| Recruitment start date | 29/10/2015 |
| Recruitment end date | 12/01/2021 |
Locations
Countries of recruitment
- Czech Republic
- Finland
- Sweden
Study participating centres
Umeå
907 37
Sweden
P.O. Box 63
Helsinki
00014
Finland
Brno
60200
Czech Republic
Sponsor information
University/education
Oncology, Norrland University Hospital (Onkologi, Norrlands Universitetssjukhus)
Umeå
901 85
Sweden
| Phone | +46 (0)90-785 28 54 |
|---|---|
| pia@cancerforskningsfonden.se | |
| Website | https://cancerforskningsfonden.se/ |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Faculty of Medicine at Umeå University, Faculty of Medicine, Umeå University, Faculty of Medicine, Medicinska fakulteten
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Cancer Foundation Finland, Cancerstiftelsen
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Northern Sweden Cancer Foundation
- Location
- Sweden
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Ioannis Gkekas, ioannis.gkekas@umu.se. The type of data that will be shared is completely anonymization for every variable and includes sex, age, cancer stage, and type of cancer. These data will be available immediately. Consent from participants was not required or obtained. Ethical and legal restrictions are in concordance with the ethical approval obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Thesis results | Doctoral thesis; study V | 21/05/2021 | 15/06/2023 | No | No |
Editorial Notes
15/06/2023: Trial's existence confirmed by the Regional Medical Review Board in Umeå, Department of Medical Strengthening (Regional etikprövningsnämnden i Umeå Avdelningen fur Medicinsk Forstkning) (Sweden).
