Colorectal CancerBLOOMSINCT06414304
Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy
An observational study of Colorectal Cancer and Colorectal Cancer Metastatic, run by OncoAtlas LLC at 2 sites in Russia.
Trial summary
Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Microsatellite instability or mismatch repair deficiency occurs in 20% of CRC, and is predominantly found in non-metastatic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Metastatic, MSI-H Colorectal Cancer
- How many people
- 30 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jun 2022to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 histologically confirmed colorectal cancer with microsatellite instability (MSI) or mismatch repair deficiency (dMMR)
Who may be able to join
- Male/female participants must be at least 18 years of age on the day of signing informed consent and have a histologically confirmed diagnosis of colorectal cancer.
- Verified MSI/dMMR positivity as measured by 5-loci PCR or 4-antibody IHC.
- The patient is scheduled to start treatment with any of the immune checkpoint inhibitors 2-4 weeks after the inclusion in the study.
- Have provided an archival tumor tissue sample obtained prior to the start of treatment with immune checkpoint inhibitor(s). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
- Patient has to be able to provide serial blood samples during the course of treatment, as well as on every follow-up tumor scan.
- The participant (or legally acceptable representative if applicable) provides written informed consent to participate in the trial.
- Have measurable disease based on RECIST 1.1.
- Have adequate organ function.
Who cannot join
- Prior treatment with immune checkpoint inhibitors.
- For female participants: pregnancy or planned pregnancy.
- The unavailability of the tumor or serial liquid biopsy samples.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
N.N.Blokhin National Medical Research Center of Oncology
Moscow, 115478
State Budgetary Institution of Healthcare of the City of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Health of the City of Moscow
Moscow, 142770
About this study
Official title: A Multi-center Observational Clinical Trial Evaluating the Dynamics of Microsatellite Instability and Genomic Profile of Colorectal Cancer in the Course of Treatment With Immune Checkpoint Inhibitors
Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Microsatellite instability or mismatch repair deficiency occurs in 20% of CRC, and is predominantly found in non-metastatic tumors. The success of the CheckMate 142 and KEYNOTE-177 clinical trials has shifted the treatment paradigm of the MSI/dMMR CRC, which has led to the adoption of immune checkpoint inhibitors (ICI) by international treatment standards. However, despite the encouraging effects of ICI, up to 30% of patients are resistant to treatment and exhibit rapid disease progression shortly after starting ICI. On the other hand, around 30% of patients treated with ICI demonstrate prolonged responses to the treatment with a duration of response of over 40 months. Furthermore, for ~10% of patients, treatment with ICI results in pseudo-progression - a phenomenon of a short-term increase followed by the decrease of the tumor volume.
Currently, the mechanisms and biomarkers associated with the response or resistance to ICI in MSI-positive CRC are largely unknown. Select studies suggest that BRAF mutations (specifically, BRAF p.V600E) might negatively affect the patients' progression-free survival following ICI, however, these data are premature.
The primary hypothesis is that the clonal heterogeneity and the evolution of MSI status of MSI-positive CRC will play a role in the development of ICI treatment resistance. The primary objective of the study is to investigate the dynamics of MSI status in serial liquid biopsy samples from patients with MSI-positive tumors receiving ICI.
Read the detailed description
This is a multicenter observational trial designed to evaluate the dynamics of microsatellite instability and the genomic profiles of CRC during immune checkpoint inhibitor treatment.
Patients with MSI/dMMR-positive tumors who are candidates for the ICI treatment will be included in the study. MSI/dMMR positivity should be confirmed with polymerase chain reaction-based (PCR) assays, immunohistochemistry (IHC) or Next-generation sequencing (NGS). Treatment with any ICI will be allowed. Upon inclusion in the study, patients will be asked to provide the pre-treatment FFPE tumor and liquid biopsy (LB) samples along with LB samples on the 14th, 28th days of ICI, and at every control study. LB samples will be collected until treatment discontinuation.
The pre-treatment FFPE samples will be tested with an alternative routine method (PCR and/or IHC, depending on what method was used for initial testing), as well as with the Solo Atlas Pro NGS panel covering common cancer-related genes and short tandem repeats for MSI detection. All LB samples will be tested with the Solo Atlas Pro NGS panel. Dynamics of MSI and genomic profiles will be correlated with the treatment outcomes.
Disease response to study treatment will be evaluated by imaging methods. Response to treatment will be determined by RECIST v1.1.
- Conditions
- Colorectal Cancer, Colorectal Cancer Metastatic, MSI-H Colorectal Cancer, dMMR Colorectal Cancer, Cancer, Colon Adenocarcinoma
- Keywords
- MSI, dMMR, Microsatellite instability, Next-generation sequencing, Immunotherapy, Immune checkpoint inhibitors, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Colonic Neoplasms, Microsatellite Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of NGS and routine methods (PCR, IHC) for MSI analysis
Concordance will be calculated using Cohen's Kappa (κ)
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
Concordance of MSI in tumor tissue and liquid biopsy (ctDNA)
Concordance will be calculated using Cohen's Kappa (κ)
Measured: Through study completion, an average of 3 years
Qualitative and quantitative status of MSI in serial liquid biopsy (ctDNA) samples
Liquid biopsy samples will be collected prior to the start of ICI, on the 14th and 28th days of therapy and at every follow-up tumor scan
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2022
- Primary completion1 Sep 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoAtlas LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- N.N. Blokhin National Medical Research Center of Oncology, Moscow Multidisciplinary Clinical Center "Kommunarka"
- Responsible party
- Sponsor
- Investigators
- Maxim Ivanov, PhD, Principal investigator, OncoAtlas LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414304
- Sponsor's protocol ID
- BLOOMSI
- Other IDs
- 22-75-10154
- Acronym
- BLOOMSI
- Status last verified
- Jun 2025
- First submitted
- 7 May 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Observational Clinical Trial Evaluating the Dynamics of Microsatellite Instability and Genomic Profile of Colorectal Cancer in the Course of Treatment With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06414304
- Acronym / sponsor ID
- BLOOMSI / BLOOMSI
- Conditions
- Colorectal Cancer, Colorectal Cancer Metastatic, MSI-H Colorectal Cancer, dMMR Colorectal Cancer, Cancer, Colon Adenocarcinoma
- Keywords
- MSI, dMMR, Microsatellite instability, Next-generation sequencing, Immunotherapy, Immune checkpoint inhibitors, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- OncoAtlas LLCIndustry (pharma, biotech, devices)
- Collaborators
- N.N. Blokhin National Medical Research Center of Oncology, Moscow Multidisciplinary Clinical Center "Kommunarka"
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 May 2024 (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.
Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Microsatellite instability or mismatch repair deficiency occurs in 20% of CRC, and is predominantly found in non-metastatic tumors. The success of the CheckMate 142 and KEYNOTE-177 clinical trials has shifted the treatment paradigm of the MSI/dMMR CRC, which has led to the adoption of immune checkpoint inhibitors (ICI) by international treatment standards. However, despite the encouraging effects of ICI, up to 30% of patients are resistant to treatment and exhibit rapid disease progression shortly after starting ICI. On the other hand, around 30% of patients treated with ICI demonstrate prolonged responses to the treatment with a duration of response of over 40 months. Furthermore, for ~10% of patients, treatment with ICI results in pseudo-progression - a phenomenon of a short-term increase followed by the decrease of the tumor volume.
Currently, the mechanisms and biomarkers associated with the response or resistance to ICI in MSI-positive CRC are largely unknown. Select studies suggest that BRAF mutations (specifically, BRAF p.V600E) might negatively affect the patients' progression-free survival following ICI, however, these data are premature.
The primary hypothesis is that the clonal heterogeneity and the evolution of MSI status of MSI-positive CRC will play a role in the development of ICI treatment resistance. The primary objective of the study is to investigate the dynamics of MSI status in serial liquid biopsy samples from patients with MSI-positive tumors receiving ICI.
Detailed description
This is a multicenter observational trial designed to evaluate the dynamics of microsatellite instability and the genomic profiles of CRC during immune checkpoint inhibitor treatment.
Patients with MSI/dMMR-positive tumors who are candidates for the ICI treatment will be included in the study. MSI/dMMR positivity should be confirmed with polymerase chain reaction-based (PCR) assays, immunohistochemistry (IHC) or Next-generation sequencing (NGS). Treatment with any ICI will be allowed. Upon inclusion in the study, patients will be asked to provide the pre-treatment FFPE tumor and liquid biopsy (LB) samples along with LB samples on the 14th, 28th days of ICI, and at every control study. LB samples will be collected until treatment discontinuation.
The pre-treatment FFPE samples will be tested with an alternative routine method (PCR and/or IHC, depending on what method was used for initial testing), as well as with the Solo Atlas Pro NGS panel covering common cancer-related genes and short tandem repeats for MSI detection. All LB samples will be tested with the Solo Atlas Pro NGS panel. Dynamics of MSI and genomic profiles will be correlated with the treatment outcomes.
Disease response to study treatment will be evaluated by imaging methods. Response to treatment will be determined by RECIST v1.1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed colorectal cancer with microsatellite instability (MSI) or mismatch repair deficiency (dMMR)
Key inclusion criteria (8 listed)
- Male/female participants must be at least 18 years of age on the day of signing informed consent and have a histologically confirmed diagnosis of colorectal cancer.
- Verified MSI/dMMR positivity as measured by 5-loci PCR or 4-antibody IHC.
- The patient is scheduled to start treatment with any of the immune checkpoint inhibitors 2-4 weeks after the inclusion in the study.
- Have provided an archival tumor tissue sample obtained prior to the start of treatment with immune checkpoint inhibitor(s). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
- Patient has to be able to provide serial blood samples during the course of treatment, as well as on every follow-up tumor scan.
Key exclusion criteria (3 listed)
- Prior treatment with immune checkpoint inhibitors.
- For female participants: pregnancy or planned pregnancy.
- The unavailability of the tumor or serial liquid biopsy samples.
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
Concordance of NGS and routine methods (PCR, IHC) for MSI analysis
Time frame: Through study completion, an average of 3 years
Concordance will be calculated using Cohen's Kappa (κ)
2 secondary outcomes
Concordance of MSI in tumor tissue and liquid biopsy (ctDNA)
Time frame: Through study completion, an average of 3 years
Qualitative and quantitative status of MSI in serial liquid biopsy (ctDNA) samples
Time frame: Through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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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. This study is not recruiting at the moment.
Maxim Ivanov, PhD principal investigator
OncoAtlas LLC
2 sites 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 Colorectal Cancer Metastatic, run by OncoAtlas LLC at 2 sites 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of NGS and routine methods (PCR, IHC) for MSI analysis (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.