NCT06562777 Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
| NCT ID | NCT06562777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Hematopoietic and Lymphatic System Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-09-15 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older on date of enrollment (Confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 2. Histologically confirmed diagnosis of cancer and plan to begin SOC immunotherapy for the treatment of cancer per FDA approval and/or National Comprehensive Cancer Network (NCCN) guidelines (Confirmed by review of cancer diagnosis and treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 3. Treating oncologist anticipates at least 6 consecutive months of SOC immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) Exclusion Criteria: 1. Diagnosed with breast, prostate, testicular, penile, or gynecologic cancer (Confirmed by review of the cancer diagnosis as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 2. Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 3. Life expectancy of \<6 months at time of enrollment per the treating oncologist (Confirmed by the professional opinion of the treating oncologist and subsequently recorded in a CRF.) 4. Concurrently receiving a non-immunotherapy treatment, including chemotherapy, biological, or targeted therapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 5. Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g. pain) (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 6. Participation in a clinical trial of experimental immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.) 7. Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.) 8. Unwilling or unable to complete consent form and surveys electronically (Confirmed by successful completion of electronic consent form and baseline survey in REDCap.) Assessment of participant eligibility is at the discretion of the Principal Investigator, Dr. Deanne Tibbitts.
Contact & Investigator
Deanne Tibbitts
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT06562777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematopoietic and Lymphatic System Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06562777 currently recruiting?
Yes, NCT06562777 is actively recruiting participants. Visit ClinicalTrials.gov or contact OHSU Knight Cancer Institute to inquire about joining.
Where is the NCT06562777 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06562777 clinical trial?
NCT06562777 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Deanne Tibbitts at OHSU Knight Cancer Institute. The trial plans to enroll 100 participants.