Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
Recruiting
Observational Study
Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
OHSU Knight Cancer Institute · Other
Who this trial is looking for
This trial is looking for adult cancer patients undergoing immunotherapy. Participants will help researchers understand the symptoms experienced during treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have a confirmed diagnosis of cancer.
I plan to start approved immunotherapy treatment.
My doctor expects that I will receive immunotherapy for at least 6 months.
You may not be able to join if
I have been diagnosed with breast, prostate, testicular, penile, or gynecologic cancer.
I have previously received immunotherapy.
My doctor believes I have a life expectancy of less than 6 months.
I am currently receiving non-immunotherapy treatments, like chemotherapy.
I am currently receiving radiation therapy.
I am participating in another clinical trial for experimental immunotherapy.
I cannot complete surveys without help.
I am unwilling or unable to complete the consent form and surveys online.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
Trial Locations
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Status
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 treatmen…
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.
Contacts
No contact information available.
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