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DNA Adductomics for Colorectal Cancer Investigation (adductomics)

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ClinicalTrials.gov Identifier: NCT04865601
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

Brief 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. 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.

Condition or disease Intervention/treatment
Colorectal Cancer Familial Adenomatous Polyposis Hereditary Non-polyposis Colon Cancer Lynch Syndrome Other: resectomy of the colon

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Novel DNA Adductomics Methodological Developments for Research in Colon Cancer
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
CRC
Patient affected by any sporadic colorectal cancer
Other: resectomy of the colon
The patient scheduled for colon resectomy are included in the study

FAP
Patients affected by familial adenomatous polyposis coli
Other: resectomy of the colon
The patient scheduled for colon resectomy are included in the study

HNPCC
Patient affected by hereditary non polyposis colorectal cancer
Other: resectomy of the colon
The patient scheduled for colon resectomy are included in the study

Lynch
patient affected by lynch syndrome
Other: resectomy of the colon
The patient scheduled for colon resectomy are included in the study

others
Patients affected by ulcerative colitis, chron disease, diverticulitis and other colon diseases, which represent the control
Other: resectomy of the colon
The patient scheduled for colon resectomy are included in the study




Primary Outcome Measures :
  1. DNA adductome in CRC and other diseases [ Time Frame: During surgery ]
    Identification of DNA adducts in colon tissue from CRC and other diseases

  2. 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


Secondary Outcome Measures :
  1. Correlation of DNA adducts with microbiota [ Time Frame: Baseline (Before surgery) ]
    Correlation of DNA adduct in colon tissues with microbiota and microbiota metabolites in faeces

  2. Correlation of DNA adducts with CRC causes [ Time Frame: Baseline (Before surgery) ]
    Correlation of DNA adduct in colon tissues with metabolism in serum and urine


Biospecimen Retention:   Samples With DNA
Colon epithelium layer, white blood cells, serum, plasma, urine, faeces


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865601


Contacts
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Contact: Lars Ove Drasted, professor +4535332694 ldra@nexs.ku.dk
Contact: Giorgia La Barbera +4591838577 glb@nexs.ku.dk

Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen Recruiting
Copenhagen, Frederiksberg C, Denmark, 1958
Contact: Lars O Dragsted, Professor    +4535332694    ldra@nexs.ku.dk   
Contact: Mikkel Tullin, MSc    +4535330933    mtu@nexs.ku.dk   
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
Investigators
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Principal Investigator: Lars Ove O Dragsted, PhD University of Copenhagen
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Responsible Party: Professor Lars Ove Dragsted, professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04865601    
Other Study ID Numbers: M239
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Adenomatous Polyposis Coli
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases