Clinical trial · Observational
Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects
Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
NCT04242095CI-TRIAL-00125397recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
This study collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Immune System Disorder | — | UNRESOLVED | — |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection, medical record review)
- description
- Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Medical Chart Review
Primary outcomes (1)
- measure
- Establishment of a national biorepository including biospecimen and clinical data collections for future use
- timeFrame
- Up to 1 year
- description
- The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples
* REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics
* Must have received one or more IO therapeutics
* In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemotherapy, hormonal or targeted therapy, as long as these are reported
* REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:
* One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related
\*\* Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded
* One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be immune-related
* Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
\*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
* Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
* REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study \* The same patient cannot be enrolled more than once to this study due to development of subsequent irAEsReferences
Publications (0)
Data not yet available
No reference posted for this study.