AutoimmunityMININGNCT03370861
How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes
An observational study of Autoimmunity and Melanoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmunity, Melanoma, Merkel Cell Carcinoma
- What is being tested?
- Immunotherapy
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 31 Dec 2022
- 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 skin cancer planning to initiate or already on ANY type of immunotherapy.
Who may be able to join
- ≥18 years of age.
- Diagnosis of skin cancer.
- Planning to initiate or already on ANY type of immunotherapy.
- Able to provide urine and stool specimens.
Who cannot join
- Bowel resection.
- Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunotherapy Multi-omics Specimen Protocol A
The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.
Read the detailed description
Details will be available upon publication.
- Conditions
- Autoimmunity, Melanoma, Merkel Cell Carcinoma, Squamous Cell Carcinoma of the Skin, Basal Cell Carcinoma, Skin Cancer
- Being tested
- Immunotherapy
- Medical subject headings
- Autoimmune Diseases, Melanoma, Carcinoma, Merkel Cell, Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyBiological
Medications that increase the activity of the immune system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-related Adverse Events (irAEs)
Electronic medical records will be queried for specific drug-related adverse events known as immune-related Adverse Events (irAEs) including but not limited to colitis, hypophysitis, hepatitis, pneumonitis, pancreatitis, arthritis, rash, and vitiligo.
Measured: 2 years
Secondary outcomes (1)
Overall Survival
Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start8 Nov 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Subject recruitment was limited severely by the 2020-2023 COVID-19 pandemic, which led this study to be closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutoimmunityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William H. McCoy IV, MD, PhD, Washington University School of Medicine
- Investigators
- William H McCoy IV, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370861
- Sponsor's protocol ID
- MINING
- Acronym
- MINING
- Status last verified
- Aug 2024
- First submitted
- 7 Dec 2017
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy Multi-omics Specimen Protocol A
- ClinicalTrials.gov ID
- NCT03370861
- Acronym / sponsor ID
- MINING / MINING
- Conditions
- Autoimmunity, Melanoma, Merkel Cell Carcinoma, Squamous Cell Carcinoma of the Skin, Basal Cell Carcinoma, Skin Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Subject recruitment was limited severely by the 2020-2023 COVID-19 pandemic, which led this study to be closed.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Dec 2017 (actual)
- 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 research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.
Detailed description
Details will be available upon publication.
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
- Patients with skin cancer planning to initiate or already on ANY type of immunotherapy.
Key inclusion criteria (4 listed)
- ≥18 years of age.
- Diagnosis of skin cancer.
- Planning to initiate or already on ANY type of immunotherapy.
- Able to provide urine and stool specimens.
Key exclusion criteria (2 listed)
- Bowel resection.
- Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyMedications that increase the activity of the immune system. | Biological | – |
Primary outcome
Immune-related Adverse Events (irAEs)
Time frame: 2 years
Electronic medical records will be queried for specific drug-related adverse events known as immune-related Adverse Events (irAEs) including but not limited to colitis, hypophysitis, hepatitis, pneumonitis, pancreatitis, arthritis, rash, and vitiligo.
1 secondary outcome
Overall Survival
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Subject recruitment was limited severely by the 2020-2023 COVID-19 pandemic, which led this study to be closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
William H McCoy IV, MD, PhD principal investigator
Washington University School of Medicine
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 Autoimmunity and Melanoma, run by Washington University School of Medicine 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Sep 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 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?
The study was stopped early (reason given: Subject recruitment was limited severely by the 2020-2023 COVID-19 pandemic, which led this study to be closed.). Results are not available in the source record.
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?
Immune-related Adverse Events (irAEs) (time frame: 2 years). 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 Sep 2024.