Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

ConditionMalignancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAlliance for Clinical Trials in Oncology

About this trial

This trial 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Received a regimen containing one or more immuno-oncology therapeutics

One or more serious (Grade 3-4) AEs that are likely immune-related

One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related

Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment

Disqualifiers

None

Trial population

Patients who have received one or more immuno-oncology therapeutics and experienced one or more serious adverse events (AEs)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of tissue, blood, and stool samples

  • Medical Chart Review

    Other intervention

    Review of medical records

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: Observational (biospecimen collection, medical record review)2 interventions

Trial outcomes

Primary outcomes

1

Establishment of a national biorepository including biospecimen and clinical data collections for future use

The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.

Time frame
Up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator