Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

NCT03941080 | Recruiting

• 1 other identifier: 201900296
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

In this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable CRC are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

Conditions

Colorectal Cancer Metastatic

Keywords

colorectal cancer; gut microbiome

Outcome Measures

Primary Outcomes (1)

• Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer

  To determine which bacteria species in the microbiome predict response to conventional systemic anti-tumor therapy according to RECIST v1.1 for metastatic or irresectable colorectal cancer

  2 years

Secondary Outcomes (1)

• Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer

  2 years

Study Arms (1)

GIMICC

Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.

Diagnostic Test: fecal sample; Behavioral: questionnaire; Diagnostic Test: Blood sample

Interventions

fecal sample DIAGNOSTIC_TEST

patients will collect fecal samples at home prior to treatment and at 3 months after start of treatment at the time of response evaluation using a standard stool-collection-kit.

GIMICC

questionnaire BEHAVIORAL

At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.

GIMICC

Blood sample DIAGNOSTIC_TEST

4 tubes of blood are collected prior to treatment and at 3 months after start of treatment at the time of response evaluation and sent to the UMCG for storage.

GIMICC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who present in the hospitals of the North Netherlands Colorectal Cancer Network. The participating hospitals together cover 10% of the Dutch population. Given that 13.000 patients yearly are diagnosed with colorectal cancer of which one third will develop metastatic or irresectable disease (www.iknl.nl), in the hospitals participating in this study 400 potential patients will present. Taking into account that about 50% do not fulfil in- and exclusion criteria or will refuse to participate, about 200 patients per year are expected to be included.

You may qualify if:

• Age ≥ 18 years
• Patients with histologically confirmed CRC with an indication for palliative systemic anti-tumor therapy (ANY combination of chemotherapy with/without anti-VEGF of anti-EGFR therapy)
• Measurable disease according to RECIST v1.1.
• Stored pathological specimens available
• Life expectancy ≥ 12 weeks
• Signed Informed Consent Form
• Ability to comply with protocol

You may not qualify if:

• Previous (neo)adjuvant chemotherapy \< 6 months
• Previous radiotherapy on the small or large intestine \< 1month
• Previous surgery of the small or large intestine \< 1 month
• Uncontrolled inflammatory bowel disease
• Participation in a study with a potential effect on the gut microbiome

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (10)

Wilhelmina Ziekenhuis

Assen, Netherlands

RECRUITING

Ziekenhuis Nij Smellinghe

Drachten, Netherlands

RECRUITING

Treant Zorggroep

Emmen, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Netherlands

RECRUITING

Tjongerschans Ziekenhuis

Heerenveen, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Ommelander Ziekenhuis Groep

Scheemda, Netherlands

RECRUITING

Antonius Zorggroep

Sneek, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal sample and blood

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surveys and Questionnaires; Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• J. J. de Haan, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. J. de Haan, MD, PhD

CONTACT

+31 50 3612821; j.j.de.haan@umcg.nl

D. J. de Groot, MD, PhD

CONTACT

+31 50 361 2821; d.j.a.de.groot@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 7, 2019
• Study Start: September 9, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

NL (10)