Colorectal CancerMSIRus22NCT05495776
Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer
An observational study of Colorectal Cancer and Lynch Syndrome, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Lynch Syndrome, Hereditary Colorectal Cancer
- How many people
- 2,500 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2022to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor
Who may be able to join
- Provision of written informed consent;
- Patients with histologically verified colon adenocarcinoma or patients with histologically verified synchronous neoplasms who have not previously received treatment for a second tumor;
- Age ≥ 18 years;
- Absence of antitumor treatment for a real tumor (it is allowed to include patients who have a history of antitumor treatment for other malignant tumors, if the period after treatment is more than 12 months).
- The ability of the patient, according to the Researcher, to fulfill the requirements of the Protocol;
Who cannot join
- Patients receiving chemotherapy or radiotherapy for colon cancer at the time of screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
Alexey Tsukanov, Phd, +79167563957, tsukanov81@rambler.ru
About this study
Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia
Read the detailed description
Blood and tumor samples will be obtained from enrolled patients. 4 ml of venous blood samples will be taken into a tube with EDTA and stored at -20 0C. Tumor samples will be taken during endoscopy or surgical treatment, embedded in paraffin and stored at room temperature.
Microsatellite instability in the tumor tissue will be determined by any method available in the participating center (immunohistochemical or molecular genetic study). In case of detection of microsatellite instability/deficiency in the repair system of unpaired bases blood samples will be analyzed for the fact that germinal mutations in the DNA mismatch repair genes.
Patients will be followed up for 5 years after enrollment. During follow up correlation of spectrum of germinal mutations with clinical data, effectiveness of therapy with immune checkpoint inhibitors, the spectrum of malignant neoplasms in the families of patients with Lynch syndrome, the impact of the presence of microsatellite instability/deficiency in the DNA mismatch repair genes on treatment tactics in the Russian Federation will be assessed.
- Conditions
- Colorectal Cancer, Lynch Syndrome, Hereditary Colorectal Cancer, MSI
- Keywords
- Colorectal Cancer, Lynch Syndrome, Hereditary Colorectal Cancer, MSI, Frequency
- Medical subject headings
- Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer | Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of microsatellite instability and Lynch syndrome
To assess the frequency of microsatellite instability and Lynch syndrome in the population of patients with colorectal cancer in the Russian Federation.
Measured: up to 5 years
Secondary outcomes (5)
Frequency of occurrence of microsatellite instability/deficiency
Assessment of the frequency of occurrence of microsatellite instability/deficiency in the repair system of unpaired bases in second tumors in patients with colorectal cancer of various stages.
Measured: up to 5 years
Spectrum of germinal mutations in Lynch syndrome
The mlh1, msh2, msh6, pms2 and epcam genes will be examined for the presence of all types of pathogenic variants in patients with MSI in colon tumor. The possible correlation of gene-phenotype and pathogenic variants of each gene-phenotype will also be studied. To detect MSI in a tumor sample, need to do the fragment analysis (markers NR21, NR24, NR27, BAT25, BAT26). Рatients with MSI in the tumor will have DNA diagnostics of MMR EPCAM genes by sequencing and MLPA . The MMR and EPCAM genes will be examined in DNA isolated from blood lymphocytes.
Measured: up to 5 years
Spectrum of malignant neoplasms
The family history of all oncological diseases will be studied to find out the main target organs of patients with Lynch syndrome in Russia
Measured: up to 5 years
Effectiveness of therapy with immune checkpoint inhibitors
The frequency will be compared: the frequency of objective response rate (RECIST 1.1) while using immune checkpoint inhibitors in metastatic colon cancer and microsatellite instability associated/not associated with Lynch syndrome
Measured: up to 5 years
Impact of the presence of microsatellite instability/deficiency
The frequency of adjuvant chemotherapy in stages II-III of colon cancer in the presence of microsatellite instability / deficiency in the repair system of unpaired bases in real clinical practice will be evaluated
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Collaborators
- The Loginov MCSC MHD, Pirogov National Medical Surgical Center, Moscow City Oncological Hospital No. 62 MHD, City Clinical Oncological Hospital No. 1 MHD, Moscow Multidisciplinary Clinical Center "Kommunarka", D.D. Pletnev City Clinical Hospital MHD, Botkin Hospital MHD, Clinic K+31
- Responsible party
- Sponsor
- Investigators
- Alexey Tsukanov, PhD, Principal investigator, Head of the Department of Laboratory Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495776
- Sponsor's protocol ID
- 01082022
- Acronym
- MSIRus22
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Before the start of the study, at the initiating visit, the monitor, together with the researchers and their staff, will review the protocol and the CRF. During the study, the monitor will regularly communicate remotely with the research center and check the process of inclusion of patients, the completeness of maintaining medical records of patients, the correctness of filling out the CRF. The researcher must provide the monitor with access to the relevant hospital documentation and other medical records to verify their compliance with the data recorded in the IRC. The data identifying the patient's identity will remain confidential.
Publications
Semenov D, Achkasov S, Bodunova N, Avdalyan A, Barinov A, Chegodar A, Chernikovskiy I, Chizhikov N, Danilov M, Demidova I, Dmitriev V, Erygin D, Fedyanin M, Galkin V, Ivanilova D, Kanner D, Karnaukhov N, Karpov O, Khatkov I, Kolesnikova D, Kotova E, Maynovskaia O, Penzin O, Pikunov D, Pulin A, Savelov N, Semenova A, Shatalov V, Shubin V, Sklyar I, Yudin O, Zakurdaev E, Pokataev I, Tsukanov A. Prevalence and clinicopathological correlates of MSI/dMMR in colorectal cancer: a prospective multicenter registry study from Russia. Front Oncol. 2026 Aug 18;16:1883562. doi: 10.3389/fonc.2026.1883562. eCollection 2026.
PubMed 42682457
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05495776
- Acronym / sponsor ID
- MSIRus22 / 01082022
- Conditions
- Colorectal Cancer, Lynch Syndrome, Hereditary Colorectal Cancer, MSI
- Keywords
- Colorectal Cancer, Lynch Syndrome, Hereditary Colorectal Cancer, MSI, Frequency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Collaborators
- The Loginov MCSC MHD, Pirogov National Medical Surgical Center, Moscow City Oncological Hospital No. 62 MHD, City Clinical Oncological Hospital No. 1 MHD, Moscow Multidisciplinary Clinical Center "Kommunarka", D.D. Pletnev City Clinical Hospital MHD, Botkin Hospital MHD, Clinic K+31
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia
Detailed description
Blood and tumor samples will be obtained from enrolled patients. 4 ml of venous blood samples will be taken into a tube with EDTA and stored at -20 0C. Tumor samples will be taken during endoscopy or surgical treatment, embedded in paraffin and stored at room temperature.
Microsatellite instability in the tumor tissue will be determined by any method available in the participating center (immunohistochemical or molecular genetic study). In case of detection of microsatellite instability/deficiency in the repair system of unpaired bases blood samples will be analyzed for the fact that germinal mutations in the DNA mismatch repair genes.
Patients will be followed up for 5 years after enrollment. During follow up correlation of spectrum of germinal mutations with clinical data, effectiveness of therapy with immune checkpoint inhibitors, the spectrum of malignant neoplasms in the families of patients with Lynch syndrome, the impact of the presence of microsatellite instability/deficiency in the DNA mismatch repair genes on treatment tactics in the Russian Federation will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer | – | –Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor
Key inclusion criteria (5 listed)
- Provision of written informed consent;
- Patients with histologically verified colon adenocarcinoma or patients with histologically verified synchronous neoplasms who have not previously received treatment for a second tumor;
- Age ≥ 18 years;
- Absence of antitumor treatment for a real tumor (it is allowed to include patients who have a history of antitumor treatment for other malignant tumors, if the period after treatment is more than 12 months).
- The ability of the patient, according to the Researcher, to fulfill the requirements of the Protocol;
Key exclusion criteria (1 listed)
- Patients receiving chemotherapy or radiotherapy for colon cancer at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of microsatellite instability and Lynch syndrome
Time frame: up to 5 years
To assess the frequency of microsatellite instability and Lynch syndrome in the population of patients with colorectal cancer in the Russian Federation.
5 secondary outcomes
Frequency of occurrence of microsatellite instability/deficiency
Time frame: up to 5 years
Spectrum of germinal mutations in Lynch syndrome
Time frame: up to 5 years
Spectrum of malignant neoplasms
Time frame: up to 5 years
Effectiveness of therapy with immune checkpoint inhibitors
Time frame: up to 5 years
Impact of the presence of microsatellite instability/deficiency
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 42682457Semenov D, Achkasov S, Bodunova N, Avdalyan A, Barinov A, Chegodar A, Chernikovskiy I, Chizhikov N, Danilov M, Demidova I, Dmitriev V, Erygin D, Fedyanin M, Galkin V, Ivanilova D, Kanner D, Karnaukhov N, Karpov O, Khatkov I, Kolesnikova D, Kotova E, Maynovskaia O, Penzin O, Pikunov D, Pulin A, Savelov N, Semenova A, Shatalov V, Shubin V, Sklyar I, Yudin O, Zakurdaev E, Pokataev I, Tsukanov A. Prevalence and clinicopathological correlates of MSI/dMMR in colorectal cancer: a prospective multicenter registry study from Russia. Front Oncol. 2026 Aug 18;16:1883562. doi: 10.3389/fonc.2026.1883562. eCollection 2026.
- Individual participant dataSharing planned: Yes. Before the start of the study, at the initiating visit, the monitor, together with the researchers and their staff, will review the protocol and the CRF. During the study, the monitor will regularly communicate remotely with the research center and check the process of inclusion of patients, the completeness of maintaining medical records of patients, the correctness of filling out the CRF. The researcher must provide the monitor with access to the relevant hospital documentation and other medical records to verify their compliance with the data recorded in the IRC. The data identifying the patient's identity will remain confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexey Tsukanov, PhD principal investigator
Head of the Department of Laboratory Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lynch Syndrome, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitrii Semenov, PhD (+7 (985) 2632870, dr.semenov@inbox.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of microsatellite instability and Lynch syndrome (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.