Malignant MelanomaNCT02784366
GI Complications in Cancer Immunotherapy Patients
An observational study of Malignant Melanoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Mar 2024
- 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: Patients with a diagnosis of cancer who have undergone or will be undergoing immunotherapy will be eligible for recruitment.
Who may be able to join
- Confirmed diagnosis of cancer
- Currently undergoing or have undergone immunotherapy
Who cannot join
- History of a total colectomy
- History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
- History of colitis on chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Elizabeth Andrews, BS, 617-724-2090, eaandrews@mgh.harvard.edu
Keri Sullivan, BS, 617-724-5955, ksullivan79@mgh.harvard.edu
About this study
The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.
Read the detailed description
Primary objective
- To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy
Secondary objective
- Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy
- Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications
- Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy
- Conditions
- Malignant Melanoma
- Keywords
- Cancer immunotherapy, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer immunotherapy patients - no GI side effect | Cancer immunotherapy patients who do not develop GI side effects. | |
| Cancer immunotherapy patients - develop GI side effects | Cancer immunotherapy patients who develop GI side effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI disease activity
To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.
Measured: 12 weeks
Biospecimen collection
To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startAug 2015
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Michael Dougan, Massachusetts General Hospital
- Investigators
- Michael Dougan, MD, PhD, Principal investigator, Massachusetts General HospitalRyan J Sullivan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784366
- Sponsor's protocol ID
- 15302
- Status last verified
- Apr 2022
- First submitted
- 6 May 2016
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI Complications in Cancer Immunotherapy Patients
- ClinicalTrials.gov ID
- NCT02784366
- Acronym / sponsor ID
- 15302
- Conditions
- Malignant Melanoma
- Keywords
- Cancer immunotherapy, Ipilimumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Aug 2015
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 27 May 2016 (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 purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.
Detailed description
Primary objective
- To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy
Secondary objective
- Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy
- Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications
- Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer immunotherapy patients - no GI side effect | – | –Cancer immunotherapy patients who do not develop GI side effects. |
| Cancer immunotherapy patients - develop GI side effects | – | –Cancer immunotherapy patients who develop GI side effects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of cancer who have undergone or will be undergoing immunotherapy will be eligible for recruitment.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of cancer
- Currently undergoing or have undergone immunotherapy
Key exclusion criteria (3 listed)
- History of a total colectomy
- History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
- History of colitis on chemotherapy
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
GI disease activity
Time frame: 12 weeks
To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.
Biospecimen collection
Time frame: 12 weeks
To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
Michael Dougan, MD, PhD principal investigator
Massachusetts General Hospital
Ryan J Sullivan, MD principal investigator
Massachusetts General Hospital
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 Malignant Melanoma, run by Massachusetts General Hospital at 1 site in United States.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Andrews, BS (617-724-2090, eaandrews@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI disease activity (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 5 Apr 2022.