Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

2,240 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