Observing sex differences in symptoms during cancer immunotherapy

INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)

This study looks at the different symptoms men and women experience during cancer immunotherapy to see how their reports match up with what doctors observe.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OHSU Knight Cancer Institute (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06562777 on ClinicalTrials.gov

What this trial studies

This observational study aims to understand the symptoms experienced by patients undergoing immunotherapy for cancer, focusing on sex differences in these symptoms. The primary objectives include characterizing immune-related adverse events reported by patients and assessing the discrepancies between clinician evaluations and patient reports based on gender. Patients will complete surveys and have their medical records reviewed to gather comprehensive data on their experiences during treatment. The study is non-interventional and relies on patient-reported outcomes and clinical assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed cancer diagnosis who are about to start standard of care immunotherapy.

Not a fit: Patients diagnosed with breast, prostate, testicular, penile, or gynecologic cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of how immunotherapy affects different genders, leading to improved patient care and tailored treatment approaches.

How similar studies have performed: While there is ongoing research into sex differences in cancer treatment responses, this specific observational approach focusing on immunotherapy symptoms is relatively novel.

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.

Where this trial is running

Portland, Oregon

• OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)

Study contacts

• Principal investigator: Deanne Tibbitts — OHSU Knight Cancer Institute

Conditions Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm