MelanomaCOLIPINCT02600143
Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.
An observational study of Melanoma and Colitis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 123 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2013to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300
Who may be able to join
- Patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)
- Signed written informed consent.
- Able to comply with the protocol.
Who cannot join
- 1. Patients with a pre-existing colitis (e.g. Crohn's disease, ulcerative colitis).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.
Read the detailed description
Immunotherapy with immune checkpoint-inhibitors is standard treatment for patients with melanoma. However, in about 15% of patients treated with Ipilimumab a grade 3-4 colitis will occur. In programmed cell death protein 1 (PD1) inhibitors colitis is also seen as adverse event, although less prominent. We want to find a good predictive biomarker to select patients that are prone to colitis.So far no test is available that might be predictive whether a patient will develop a grade 3-4 colitis.
The study will consists of four parts: 1.) to identify a genetic profile associated with ipilimumab-induced colitis, 2.) to identify predictive (serum or fecal) biomarkers for ipilimumab-induced colitis, 3.) to study the tissue of ipilimumab-induced colitis and 4) to study the role of the gut microbiome in the development of colitis. Patients are able to participate in one, or more parts of the study.
- Keywords
- Melanoma, Colitis, Ipilimumab, Nivolumab, Pembrolizumab
- Medical subject headings
- Melanoma, Colitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic predisposition for immunotherapy-induced colitis
Difference in genetic profile on 99 confirmed inflammatory bowel disease (IBD) loci between patients who develop immunotherapy-induced colitis and who do not.
Measured: 1 week
Secondary outcomes (4)
Predictive biomarkers for immunotherapy-induced colitis in stool and serum
Comparison of calprotectin levels in the stool and serum-levels of C reactive protein (CRP), endotoxin, citrulline, intestinal fatty acid-binding protein (I-FABP), calprotectin and interleukin 8 (IL8) between patients who develop immunotherapy-induced colitis and who do not.
Measured: Day 0, 21, 42, 63
Clinical scoring system of colitis
Prediction of (severity of) colitis based on symptomatology measured with the MAYO score and BRISTOL stool scale.
Measured: Day -7 to 85
Histological assessment of colon biopsies in patients that develop colitis
Immunotherapy-induced colitis will be assessed in colon biopsies when a sigmoidoscopy has to be performed for diagnostic reasons.
Measured: 1 day
Analysis of the gut microbiome in stool samples
Microbiome analysis in stool collected before treatment and at 3, 6, and 9 weeks and correlation with development of immunotherapy-induced colitis.
Measured: Day 0, 21, 42, 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startAug 2013
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G. A.P. Hospers, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600143
- Sponsor's protocol ID
- METc 2012/085
- Acronym
- COLIPI
- Status last verified
- May 2024
- First submitted
- 3 Nov 2015
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.
- ClinicalTrials.gov ID
- NCT02600143
- Acronym / sponsor ID
- COLIPI / METc 2012/085
- Keywords
- Melanoma, Colitis, Ipilimumab, Nivolumab, Pembrolizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.
Detailed description
Immunotherapy with immune checkpoint-inhibitors is standard treatment for patients with melanoma. However, in about 15% of patients treated with Ipilimumab a grade 3-4 colitis will occur. In programmed cell death protein 1 (PD1) inhibitors colitis is also seen as adverse event, although less prominent. We want to find a good predictive biomarker to select patients that are prone to colitis.So far no test is available that might be predictive whether a patient will develop a grade 3-4 colitis.
The study will consists of four parts: 1.) to identify a genetic profile associated with ipilimumab-induced colitis, 2.) to identify predictive (serum or fecal) biomarkers for ipilimumab-induced colitis, 3.) to study the tissue of ipilimumab-induced colitis and 4) to study the role of the gut microbiome in the development of colitis. Patients are able to participate in one, or more parts of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300
Key inclusion criteria (3 listed)
- Patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)
- Signed written informed consent.
- Able to comply with the protocol.
Key exclusion criteria (1 listed)
- 1. Patients with a pre-existing colitis (e.g. Crohn's disease, ulcerative colitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic predisposition for immunotherapy-induced colitis
Time frame: 1 week
Difference in genetic profile on 99 confirmed inflammatory bowel disease (IBD) loci between patients who develop immunotherapy-induced colitis and who do not.
4 secondary outcomes
Predictive biomarkers for immunotherapy-induced colitis in stool and serum
Time frame: Day 0, 21, 42, 63
Clinical scoring system of colitis
Time frame: Day -7 to 85
Histological assessment of colon biopsies in patients that develop colitis
Time frame: 1 day
Analysis of the gut microbiome in stool samples
Time frame: Day 0, 21, 42, 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. A.P. Hospers, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Colitis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic predisposition for immunotherapy-induced colitis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.