Clinical trial · Observational
How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes
Immunotherapy Multi-omics Specimen Protocol A
NCT03370861CI-TRIAL-00080458MININGterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Subject recruitment was limited severely by the 2020-2023 COVID-19 pandemic, which led this study to be closed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmunity | — | UNRESOLVED | — |
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Biological | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Immune-related Adverse Events (irAEs)
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 2 years
- description
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥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. Exclusion Criteria: * Bowel resection. * Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.