To analyze the gut microbiome in relation to response and toxicity in a prospective cohort of patients with newly diagnosed metastasized or irresectable colorectal carcinoma treated with standard systemic therapy.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To predict which patients will develop a partial or complete response to
systemic treatment based on the characteristics of the gut microbiome.
Secondary outcome
- To determine which bacteria in the pre-treatment gut microbiome predict
serious side effects of conventional systemic anti-tumor therapy for metastatic
or irresectable colorectal cancer.
- To determine the relation between alterations of the gut microbiome and
bacterial metabolites during systemic anti-tumor therapy and efficacy and
toxicity of systemic anti-tumor therapy.
Background summary
A better understanding of the composition, function and dynamics of the gut
microbiome before and during systemic anti-tumor therapy might help to identify
factors that can be influenced during the treatment of patients with
metastasized or irresectable colorectal carcinoma.
Study objective
To analyze the gut microbiome in relation to response and toxicity in a
prospective cohort of patients with newly diagnosed metastasized or
irresectable colorectal carcinoma treated with standard systemic therapy.
Study design
A prospective multicentre observational, investigator-sponsored study.
Study burden and risks
In short, patients will be informed about this study by their own oncologist.
When informed consent is given, 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. At the day of
sampling, patients fill out a brief questionnaire about established factors
that can change the microbiome such as concurrent use of antibiotics or proton
pump inhibitors. Patients will send the fecal sample and questionnaire by mail
to the UMCG. During the next visit at their local hospital, 4 tubes of blood
are collected and sent to the UMCG for storage. The risk of fecal collection
and blood draws is considered negligible. Radiological response evaluation
takes place approximately 12 weeks after start of therapy using RECIST v1.1 as
part of standard treatment. No extra hospital visits are required.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Patients with histologically confirmed CRC with an indication for
neo-adjuvant or palliative systemic anti-tumor therapy (ANY combination of
chemotherapy with/without anti-VEGF of anti-EGFR therapy, or immunotherapy)
- Measurable disease according to RECIST v1.1.
- Stored pathological specimens available
- Life expectancy >= 12 weeks
- Signed Informed Consent Form
- Ability to comply with protocol
Exclusion criteria
- Previous (neo)adjuvant chemotherapy < 6 months
- Previous radiotherapy on the small or large intestine < 1 month
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03941080 |
| CCMO | NL69836.042.19 |