Colorectal CanceradductomicsNCT04865601
DNA Adductomics for Colorectal Cancer Investigation
An observational study of Colorectal Cancer and Familial Adenomatous Polyposis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the colon serve as controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Familial Adenomatous Polyposis, Hereditary Non-polyposis Colon Cancer
- What is being tested?
- resectomy of the colon
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2021to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be selected among the patients with either FAP, Lynch syndrome, other HNPCC, sporadic colorectal cancer, ulcerative colitis or other conditions who are scheduled for whole or partial resection of their colon at Hvidovre hospital.
Who may be able to join
- Patients with either FAP, Lynch syndrome, other HNPCC, sporadic colorectal cancer, ulcerative colitis or other conditions who are scheduled for whole or partial resection of their colon
Who cannot join
- Any condition that makes the investigator or hospital personnel doubt that voluntary participation isfeasible.
- Patients who are not able to understand and sign the informed consent form for any reason, including lack of a sufficient period of time to consider their participation.
- Patients who are below 18 years of age.
- Patients who donated blood to a blood bank within 3 months prior to their operation.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg C, 1958
Lars O Dragsted, Professor, +4535332694, ldra@nexs.ku.dk
Giorgia La Barbera, Assist. Professor, glb@nexs.ku.dk
About this study
Official title: Novel DNA Adductomics Methodological Developments for Research in Colon Cancer
This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the colon serve as controls. In addition, surrogate samples such as white blood cells are investigated for the presense of adducts while blood plasma and urine are investigated for the presense of DNA-repair products.
Read the detailed description
Colorectal cancer (CRC) develops as a result of multiple genetic mutations causing normal intestinal epithelium to transform into a colorectal carcinoma. Genetic mutations may be caused by many different genetic events including chemical damage to the DNA nucleosides. These chemical modifications are due to both exogenous compounds coming from diet, environment and gut microbiota, or endogenous compounds produced by our own metabolic processes like inflammation and oxidative stress. Such genetic alteration is thought to be the starting event leading to development of sporadic CRC. However, there is little understanding on which DNA nucleoside modifications are associated with increased risk of CRC and their mechanism of action. The study of these DNA nucleoside modifications has been addressed in the recent years by a new research field, called DNA adductomics. DNA adductomics uses the new advanced high resolution mass spectrometry (HRMS) instrumentations for identifying the complexes that are formed between toxic compounds and DNA, namely DNA adducts.
Some studies have been previously identified DNA adducts in CRC with older technology. However, there is not a real evidence on which DNA adducts are related to sporadic CRC, hereditary non polyposis colorectal cancer (HNPCC) and other diseases such as familial adenomatous polyposis (FAP) which turns into CRC with a 95% risk before the age of 35. The lack of more recent human studies in DNA adductomics is mainly due to the lack of appropriate analytical methods. Developing such methods requires sufficient sample material and the amount of sample in a colon biopsy is too low to be used for method development. In this study, colon epithelial tissue obtained by resection of colon during surgery will be used for developing a more sensitive method, possibly allowing DNA adduct analysis from biopsies in future studies. In order to ascertain that the developed method can differentiate the level of DNA-adducts between inherited CRC, sporadic CRC and non-CRC subjects, also materials from other groups coming to the hospital for colon resections will be obtained. By analyzing the materials obtained in a case-control manner, we might also be able to resolve whether some of the DNA adducts differ between the different CRC cases or in comparison with cancer-free subjects. This knowledge should provide a preliminary basis for suggesting prevention and intervention approaches to reduce morbidity and mortality from CRC.
However, in case-control studies, a proper selection of the subjects should be carried out by assuring gender and age balance between the control group and the CRC group. This will be difficult in the first part of the current study since 1) there is limited possibility of obtaining resected colon from healthy subjects 2) CRC incidence rates are markedly higher in men than in women, and 3) different types of CRC develop at different ages. It is also obvious that a method relying on analyses of colon resections would have a limited application in preventive medicine. A solution to these issues may be the use of appropriate surrogate samples like blood, faeces and urine. Indeed, since DNA lesions may be removed from the genome by the DNA repair system, they are often excreted in urine, in faeces, or in blood. In order to know whether we may substitute tissues with surrogate samples, we will explore whether there is a correlation between DNA-repair product level in surrogate samples and DNA adducts in colon tissues. Substituting colon tissues with surrogates, or developing a sensitive method for DNA analysis from biopsies, would allow an easier collection of the samples, giving the possibility, in the future, of performing large and controlled clinical studies as well as less invasive sampling from patients. This could allow to confirm a causal relationship between specific DNA-adducts and CRC, providing real advances in prevention and intervention approaches.
Finally, after the identification of the DNA adducts and DNA-repair products possibly associated with CRC, it will be important to identify the real cause of DNA adducts formation. Our final purpose is therefore identifying which life-style, dietary or environmental factors are possibly associated with the DNA adducts and DNA-repair products identified in colon and surrogate samples, respectively. For this purpose, we will perform a metabolic profiling of serum, urine and faeces, a microbial profiling of faeces, and we will correlate it with basic information on patient life styles about smoking, alcohol consumption and intake of red meat, e.g. factors suspected to influence risk of colonic diseases.
Establishing a causal relationship between specific DNA-adducts and CRC or other colonic diseases, and understanding the causes for DNA adducts formation, will not only yield much richer insights into the molecular defects but will also result in advances in prevention and intervention approaches.
- Conditions
- Colorectal Cancer, Familial Adenomatous Polyposis, Hereditary Non-polyposis Colon Cancer, Lynch Syndrome
- Being tested
- resectomy of the colon
- Medical subject headings
- Colorectal Neoplasms, Adenomatous Polyposis Coli, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resectomy of the colonOther
The patient scheduled for colon resectomy are included in the study
| Study group | Role | What they receive |
|---|---|---|
| CRC | Patient affected by any sporadic colorectal cancer Receives: Other: resectomy of the colon | |
| FAP | Patients affected by familial adenomatous polyposis coli Receives: Other: resectomy of the colon | |
| HNPCC | Patient affected by hereditary non polyposis colorectal cancer Receives: Other: resectomy of the colon | |
| Lynch | patient affected by lynch syndrome Receives: Other: resectomy of the colon | |
| others | Patients affected by ulcerative colitis, chron disease, diverticulitis and other colon diseases, which represent the control Receives: Other: resectomy of the colon |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA adductome in CRC and other diseases
Identification of DNA adducts in colon tissue from CRC and other diseases
Measured: During surgery
Correlation of DNA adduct and DNA repair products
Correlation of DNA adduct in colon tissues and DNA repair products in surrogate samples
Measured: Baseline (Before surgery)
Secondary outcomes (2)
Correlation of DNA adducts with microbiota
Correlation of DNA adduct in colon tissues with microbiota and microbiota metabolites in faeces
Measured: Baseline (Before surgery)
Correlation of DNA adducts with CRC causes
Correlation of DNA adduct in colon tissues with metabolism in serum and urine
Measured: Baseline (Before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars Ove O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865601
- Sponsor's protocol ID
- M239
- Acronym
- adductomics
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel DNA Adductomics Methodological Developments for Research in Colon Cancer
- ClinicalTrials.gov ID
- NCT04865601
- Acronym / sponsor ID
- adductomics / M239
- Conditions
- Colorectal Cancer, Familial Adenomatous Polyposis, Hereditary Non-polyposis Colon Cancer, Lynch Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Apr 2021 (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.
This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the colon serve as controls. In addition, surrogate samples such as white blood cells are investigated for the presense of adducts while blood plasma and urine are investigated for the presense of DNA-repair products.
Detailed description
Colorectal cancer (CRC) develops as a result of multiple genetic mutations causing normal intestinal epithelium to transform into a colorectal carcinoma. Genetic mutations may be caused by many different genetic events including chemical damage to the DNA nucleosides. These chemical modifications are due to both exogenous compounds coming from diet, environment and gut microbiota, or endogenous compounds produced by our own metabolic processes like inflammation and oxidative stress. Such genetic alteration is thought to be the starting event leading to development of sporadic CRC. However, there is little understanding on which DNA nucleoside modifications are associated with increased risk of CRC and their mechanism of action. The study of these DNA nucleoside modifications has been addressed in the recent years by a new research field, called DNA adductomics. DNA adductomics uses the new advanced high resolution mass spectrometry (HRMS) instrumentations for identifying the complexes that are formed between toxic compounds and DNA, namely DNA adducts.
Some studies have been previously identified DNA adducts in CRC with older technology. However, there is not a real evidence on which DNA adducts are related to sporadic CRC, hereditary non polyposis colorectal cancer (HNPCC) and other diseases such as familial adenomatous polyposis (FAP) which turns into CRC with a 95% risk before the age of 35. The lack of more recent human studies in DNA adductomics is mainly due to the lack of appropriate analytical methods. Developing such methods requires sufficient sample material and the amount of sample in a colon biopsy is too low to be used for method development. In this study, colon epithelial tissue obtained by resection of colon during surgery will be used for developing a more sensitive method, possibly allowing DNA adduct analysis from biopsies in future studies. In order to ascertain that the developed method can differentiate the level of DNA-adducts between inherited CRC, sporadic CRC and non-CRC subjects, also materials from other groups coming to the hospital for colon resections will be obtained. By analyzing the materials obtained in a case-control manner, we might also be able to resolve whether some of the DNA adducts differ between the different CRC cases or in comparison with cancer-free subjects. This knowledge should provide a preliminary basis for suggesting prevention and intervention approaches to reduce morbidity and mortality from CRC.
However, in case-control studies, a proper selection of the subjects should be carried out by assuring gender and age balance between the control group and the CRC group. This will be difficult in the first part of the current study since 1) there is limited possibility of obtaining resected colon from healthy subjects 2) CRC incidence rates are markedly higher in men than in women, and 3) different types of CRC develop at different ages. It is also obvious that a method relying on analyses of colon resections would have a limited application in preventive medicine. A solution to these issues may be the use of appropriate surrogate samples like blood, faeces and urine. Indeed, since DNA lesions may be removed from the genome by the DNA repair system, they are often excreted in urine, in faeces, or in blood. In order to know whether we may substitute tissues with surrogate samples, we will explore whether there is a correlation between DNA-repair product level in surrogate samples and DNA adducts in colon tissues. Substituting colon tissues with surrogates, or developing a sensitive method for DNA analysis from biopsies, would allow an easier collection of the samples, giving the possibility, in the future, of performing large and controlled clinical studies as well as less invasive sampling from patients. This could allow to confirm a causal relationship between specific DNA-adducts and CRC, providing real advances in prevention and intervention approaches.
Finally, after the identification of the DNA adducts and DNA-repair products possibly associated with CRC, it will be important to identify the real cause of DNA adducts formation. Our final purpose is therefore identifying which life-style, dietary or environmental factors are possibly associated with the DNA adducts and DNA-repair products identified in colon and surrogate samples, respectively. For this purpose, we will perform a metabolic profiling of serum, urine and faeces, a microbial profiling of faeces, and we will correlate it with basic information on patient life styles about smoking, alcohol consumption and intake of red meat, e.g. factors suspected to influence risk of colonic diseases.
Establishing a causal relationship between specific DNA-adducts and CRC or other colonic diseases, and understanding the causes for DNA adducts formation, will not only yield much richer insights into the molecular defects but will also result in advances in prevention and intervention approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CRC | – | Other: resectomy of the colonPatient affected by any sporadic colorectal cancer |
| FAP | – | Other: resectomy of the colonPatients affected by familial adenomatous polyposis coli |
| HNPCC | – | Other: resectomy of the colonPatient affected by hereditary non polyposis colorectal cancer |
| Lynch | – | Other: resectomy of the colonpatient affected by lynch syndrome |
| others | – | Other: resectomy of the colonPatients affected by ulcerative colitis, chron disease, diverticulitis and other colon diseases, which represent the control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected among the patients with either FAP, Lynch syndrome, other HNPCC, sporadic colorectal cancer, ulcerative colitis or other conditions who are scheduled for whole or partial resection of their colon at Hvidovre hospital.
Key inclusion criteria (1 listed)
- Patients with either FAP, Lynch syndrome, other HNPCC, sporadic colorectal cancer, ulcerative colitis or other conditions who are scheduled for whole or partial resection of their colon
Key exclusion criteria (4 listed)
- Any condition that makes the investigator or hospital personnel doubt that voluntary participation isfeasible.
- Patients who are not able to understand and sign the informed consent form for any reason, including lack of a sufficient period of time to consider their participation.
- Patients who are below 18 years of age.
- Patients who donated blood to a blood bank within 3 months prior to their operation.
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 |
|---|---|---|
| resectomy of the colonThe patient scheduled for colon resectomy are included in the study | Other | CRC, FAP, HNPCC, Lynch, others |
Primary outcome
DNA adductome in CRC and other diseases
Time frame: During surgery
Identification of DNA adducts in colon tissue from CRC and other diseases
Correlation of DNA adduct and DNA repair products
Time frame: Baseline (Before surgery)
Correlation of DNA adduct in colon tissues and DNA repair products in surrogate samples
2 secondary outcomes
Correlation of DNA adducts with microbiota
Time frame: Baseline (Before surgery)
Correlation of DNA adducts with CRC causes
Time frame: Baseline (Before surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- 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. This study is not recruiting at the moment.
Lars Ove O Dragsted, PhD principal investigator
University of Copenhagen
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 Familial Adenomatous Polyposis, run by University of Copenhagen at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Ove Drasted, professor (+4535332694, ldra@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA adductome in CRC and other diseases (time frame: During surgery). The study lists 2 primary outcomes in all. 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 30 Nov 2023.