Predictive Cancer ModelMTGNCT05929365
Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & Clinical Phenotype
An observational study of Predictive Cancer Model, run by Military University Hospital, Prague at 1 site in Czechia.
Trial summary
It is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. Based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Predictive Cancer Model
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2022to 31 Dec 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with colorectal neoplasia detected in diagnostic colonoscopy.
Who may be able to join
- Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
- Signed informed consent with the study and with colonoscopy
Who cannot join
- FAP, HNPCC and other hereditary CRC syndromes probands
- Colonoscopy contraindication
- Severe acute inflammatory bowel disease
- Severe comorbidities; likely non-compliance of the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Military University Hospital
Prague, 16902
Stepan Suchanek, MD., Ph.D., 973208367 ext. 00420, stepan.suchanek@uvn.cz
About this study
Official title: Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype
It is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. Based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a correlation between mutation in exon 7 of the TP53 gene and risk of early metachronous lesions development. The results also indicate that mutation phenotype (mutation profile and burden) of all lesions detected on index colonoscopy can determine risk of metachronous lesions. As not all synchronous lesions were analyzed and the surveillance colonoscopy interval was less than 3 years, this assumption could not be confirmed. In this study it is planned to perform mutation analysis of all synchronous lesions in 200 patients and correlate the data with appearance of metachronous lesions after 1, 3 and 5 years. Moreover, the mutation profile of all metachronous lesions developed during the 5 years of surveillance will be determinated and compared with mutation profile of index lesions from the same localization to verify their common biological origin. This all could help personalize the surveillance program in terms of reduction of the burden on the patient and endoscopic workplaces and risk of developing colorectal cancer in a particular patient.
Read the detailed description
The aim of this prospective study is to identify patients with recurrent colorectal lesions risk and try to design an optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype. The partial goals are: 1. Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method. 2. Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period. 3. Correlation of clinical and histopathological parameters with mutational phenotype of patient. 4. Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period. 5. Comparison of the mutation profile of lesions from the index period withthe mutation profile of metachronous lesions. 6. Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.
- Conditions
- Predictive Cancer Model
- Being tested
- colonoscopy
- Keywords
- phenotype, surveillance, colonoscopy, colorectal neoplasia, genetic mutation, metachronous lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Also called endoscopic resection
determine the mutation profile of resected colorectal neoplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype
To identify patients with high risk of metachronous colorectal lesions and try to design and optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype.
Measured: 5 years
Secondary outcomes (2)
Determination of the mutation profile colorectal lesions
Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method.
Measured: 5 years
Mutational profil of colorectal lesions
Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Predictive Cancer ModelStudies 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
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague
- Investigators
- Stepan Suchanek, assoc. prof., Principal investigator, Military University Hospital, PragueOndrej Ngo, Mgr., Study director, Institute of Biostatistics and Analyses BrnoLucie Benesova, RNDr., Study director, Genomac Research Institute PragueOndrej Majek, RNDr., Study chair, Institute of Biostatistics and Analyses BrnoTereza Halkova, Mgr., Study chair, Genomac Research Institute Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929365
- Sponsor's protocol ID
- NU22-08-00424
- Acronym
- MTG
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grega T, Kmochova K, Hejcmanova K, Ngo O, Brodyuk N, Majek O, Bures J, Urbanek P, Zavoral M, Suchanek S. Impact of narrow band imaging in prediction of histology of advanced colorectal neoplasia. Sci Rep. 2025 Jan 9;15(1):1414. doi: 10.1038/s41598-025-85669-w.
PubMed 39789214
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype
- ClinicalTrials.gov ID
- NCT05929365
- Acronym / sponsor ID
- MTG / NU22-08-00424
- Conditions
- Predictive Cancer Model
- Keywords
- phenotype, surveillance, colonoscopy, colorectal neoplasia, genetic mutation, metachronous lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2023 (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.
It is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. Based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a correlation between mutation in exon 7 of the TP53 gene and risk of early metachronous lesions development. The results also indicate that mutation phenotype (mutation profile and burden) of all lesions detected on index colonoscopy can determine risk of metachronous lesions. As not all synchronous lesions were analyzed and the surveillance colonoscopy interval was less than 3 years, this assumption could not be confirmed. In this study it is planned to perform mutation analysis of all synchronous lesions in 200 patients and correlate the data with appearance of metachronous lesions after 1, 3 and 5 years. Moreover, the mutation profile of all metachronous lesions developed during the 5 years of surveillance will be determinated and compared with mutation profile of index lesions from the same localization to verify their common biological origin. This all could help personalize the surveillance program in terms of reduction of the burden on the patient and endoscopic workplaces and risk of developing colorectal cancer in a particular patient.
Detailed description
The aim of this prospective study is to identify patients with recurrent colorectal lesions risk and try to design an optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype. The partial goals are: 1. Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method. 2. Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period. 3. Correlation of clinical and histopathological parameters with mutational phenotype of patient. 4. Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period. 5. Comparison of the mutation profile of lesions from the index period withthe mutation profile of metachronous lesions. 6. Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal neoplasia detected in diagnostic colonoscopy.
Key inclusion criteria (2 listed)
- Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
- Signed informed consent with the study and with colonoscopy
Key exclusion criteria (4 listed)
- FAP, HNPCC and other hereditary CRC syndromes probands
- Colonoscopy contraindication
- Severe acute inflammatory bowel disease
- Severe comorbidities; likely non-compliance of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopyAlso: endoscopic resectiondetermine the mutation profile of resected colorectal neoplasia | Procedure or surgery | – |
Primary outcome
Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype
Time frame: 5 years
To identify patients with high risk of metachronous colorectal lesions and try to design and optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype.
2 secondary outcomes
Determination of the mutation profile colorectal lesions
Time frame: 5 years
Mutational profil of colorectal lesions
Time frame: 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 3 Jul 2023.
- Derived from this study: PubMed 39789214Grega T, Kmochova K, Hejcmanova K, Ngo O, Brodyuk N, Majek O, Bures J, Urbanek P, Zavoral M, Suchanek S. Impact of narrow band imaging in prediction of histology of advanced colorectal neoplasia. Sci Rep. 2025 Jan 9;15(1):1414. doi: 10.1038/s41598-025-85669-w.
- Individual participant dataSharing planned: Undecided
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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.
Stepan Suchanek, assoc. prof. principal investigator
Military University Hospital, Prague
Ondrej Ngo, Mgr. study director
Institute of Biostatistics and Analyses Brno
Lucie Benesova, RNDr. study director
Genomac Research Institute Prague
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 Predictive Cancer Model, run by Military University Hospital, Prague at 1 site in Czechia.
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 2 inclusion and 4 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 3 Jul 2023. 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 Czechia. 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 Stepan Suchanek, assoc. prof. (973208367 ext. 00420, stepan.suchanek@uvn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype (time frame: 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 NCT05929365, 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 3 Jul 2023.