Gut Microbiome and Colorectal Cancer

NCT06748339 | Completed DMC

• 1 other identifier: HU.REC.H10-2024
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. In Egypt, CRC represents the seventh most common cancer. It is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target

Conditions

Colorectal Cancer

Keywords

CRC; microbiome

Outcome Measures

Primary Outcomes (2)

• The effect of food and lifestyle on microbiome

  correlation between food and lifestyle with microbiome profiles

  "through study completion, an average of 1 year"

• microbiome profile and CRC pathogensis

  correlation between microbiome profile and CRC pathogensis

  "through study completion, an average of 1 year"

Study Arms (2)

contol group

6 healthy participants

Other: no intervention

CRC group

12 newly diagnosed CRC patients

Other: no intervention

Interventions

no intervention OTHER

no intervention

CRC group; contol group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

12 newly diagnosed CRC patiens vs 6 healthy voulnteers

You may qualify if:

• Age of 40 years to 80 years
• Patients with a newly diagnosed CRC

You may not qualify if:

• Patients with previously known CRC
• Pregnancy or Lactation
• Abdominal surgery within/up to 6 months prior to sample collection
• Antibiotics, corticosteroids, or probiotics up to three months prior to sample collection
• History of other types of cancer
• Subjects on a special diet
• Diabetes, liver, or kidney diseases
• CRC patients who used enema or underwent colonoscopy up to one week before sample collection.

Sponsors & Collaborators

• Heliopolis University: lead

Study Sites (1)

cairo university Hopitals (elKasr ELieny )

Cairo, Egypt

Location

Related Publications (1)

• Baas FS, Brusselaers N, Nagtegaal ID, Engstrand L, Boleij A. Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis. Cell Host Microbe. 2024 Aug 14;32(8):1235-1247. doi: 10.1016/j.chom.2024.07.008.

  PMID: 39146796 BACKGROUND

Related Links

• Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from fecal samples

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• sara M eladwy

  Heliopolis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2024
• Primary Completion: September 17, 2024
• Study Completion: December 17, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)