DNA Adductomics for Colorectal Cancer Investigation

NCT04865601 | Unknown DMC

• 1 other identifier: M239
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Familial Adenomatous Polyposis; Hereditary Non-polyposis Colon Cancer; Lynch Syndrome

Outcome Measures

Primary Outcomes (2)

• DNA adductome in CRC and other diseases

  Identification of DNA adducts in colon tissue from CRC and other diseases

  During surgery

• Correlation of DNA adduct and DNA repair products

  Correlation of DNA adduct in colon tissues and DNA repair products in surrogate samples

  Baseline (Before surgery)

Secondary Outcomes (2)

• Correlation of DNA adducts with microbiota

  Baseline (Before surgery)

• Correlation of DNA adducts with CRC causes

  Baseline (Before surgery)

Study Arms (5)

CRC

Patient affected by any sporadic colorectal cancer

Other: resectomy of the colon

FAP

Patients affected by familial adenomatous polyposis coli

Other: resectomy of the colon

HNPCC

Patient affected by hereditary non polyposis colorectal cancer

Other: resectomy of the colon

Lynch

patient affected by lynch syndrome

Other: resectomy of the colon

others

Patients affected by ulcerative colitis, chron disease, diverticulitis and other colon diseases, which represent the control

Other: resectomy of the colon

Interventions

resectomy of the colon OTHER

The patient scheduled for colon resectomy are included in the study

CRC; FAP; HNPCC; Lynch; others

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Colon epithelium layer, white blood cells, serum, plasma, urine, faeces

MeSH Terms

Conditions

Colorectal Neoplasms; Adenomatous Polyposis Coli; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lars Ove O Dragsted, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Ove Drasted, professor

CONTACT

+4535332694; ldra@nexs.ku.dk

Giorgia La Barbera

CONTACT

+4591838577; glb@nexs.ku.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: February 15, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DK (1)