Kingman, Arizona 86401

  • Malignancy

Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth). OUTLINE: 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.


Criteria:

Inclusion Criteria: - Received a regimen containing one or more immuno-oncology therapeutics - Must have experienced one or more of the following: - 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 ** 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 - Has not previously been registered to this study


Study is Available At:


Original ID:

A151804


NCT ID:

NCT04242095


Secondary ID:

NCI-2019-07113


Study Acronym:


Brief Title:

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


Official Title:

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

240


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:David Kozono, MD, PhD
Study Chair
Brigham and Women's Hospital
Primary Contact:David Kozono, MD, PhD
617-632-5734
dkozono@bwh.harvard.edu

Study Dates

Start Date:January 31, 2020
Completion Date:February 2025
Completion Type:Anticipated
Primary Completion Date:October 2022
Primary Completion Type:Anticipated
Verification Date:September 2022
Last Changed Date:September 25, 2022
First Received Date:January 23, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Establishment of a national biorepository including biospecimen and clinical data collections for future use
Time Frame:Up to 1 year
Safety Issues:False
Description:The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.

Study Interventions

Intervention Type:Procedure
Name:Biospecimen Collection
Description:Undergo collection of tissue, blood, and stool samples
Arm Name:Observational (biospecimen collection, medical rec
Intervention Type:Other
Name:Medical Chart Review
Description:Review of medical records
Arm Name:Observational (biospecimen collection, medical rec

Study Arms

Study Arm Type:Other
Arm Name: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Tissue, blood, stool
Study Population: Patients who have received one or more immuno-oncology therapeutics and experienced one or more serious adverse events (AEs)
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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