RECRUITING

Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

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Conditions

Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.

Official Title

Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

Quick Facts

Study Start:2021-09-13
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04871542

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial
  2. * Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration
  3. * Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE
  4. * Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration
  5. * Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:
  6. * =\< Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)
  7. * =\< Grade 2 for neuropathy and/or alopecia
  8. * Grade 3 or less for any hematologic side effects
  9. * Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration
  10. * Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer
  11. * Participants must be at least 18 years of age
  12. * Participants must complete their history and physical examination within 28 days prior to registration
  13. * Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments
  14. * Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments
  15. * Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration
  16. * Participants must be willing to participate in PRO data collection
  17. * Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users)
  18. * Participants must be offered the opportunity to participate in the optional specimen banking
  19. * Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  20. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Krishna S Gunturu
PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network

Study Locations (Sites)

Mary Greeley Medical Center
Ames, Iowa, 50010
United States
McFarland Clinic PC - Ames
Ames, Iowa, 50010
United States
McFarland Clinic PC-Boone
Boone, Iowa, 50036
United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, 50501
United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, 50129
United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, 50158
United States

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

  • Krishna S Gunturu, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-13
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-09-13
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Solid Neoplasm