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Trial record 1 of 1 for:    A151804
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Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

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ClinicalTrials.gov Identifier: NCT04242095
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date January 23, 2020
First Posted Date January 27, 2020
Last Update Posted Date March 6, 2020
Actual Study Start Date January 31, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2020)
Establishment of a national biorepository including biospecimen and clinical data collections for future use [ Time Frame: Up to 1 year ]
The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Brief Summary 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.
Detailed Description

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 3-5) 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue, blood, stool
Sampling Method Non-Probability Sample
Study Population Patients who have received one or more immuno-oncology therapeutics and experienced one or more serious adverse events (AEs)
Condition Malignancy
Intervention
  • Procedure: Biospecimen Collection
    Undergo collection of tissue, blood, and stool samples
  • Other: Medical Chart Review
    Review of medical records
Study Groups/Cohorts Observational (biospecimen collection, medical record review)
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.
Interventions:
  • Procedure: Biospecimen Collection
  • Other: Medical Chart Review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2020)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2025
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Must have received one or more IO therapeutics
  • Must have experienced one or more of the following:

    • One or more serious (grade 3-5) AEs that are likely immune-related
    • Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
    • 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: David Kozono, MD, PhD 617-632-5734 dkozono@bwh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04242095
Other Study ID Numbers A151804
NCI-2019-07113 ( Registry Identifier: NCI Clinical Trial Reporting Program )
U10CA180821 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: David Kozono, MD, PhD Brigham and Women's Hospital
PRS Account Alliance for Clinical Trials in Oncology
Verification Date March 2020