Hematopoietic and Lymphatic System NeoplasmNCT06562777
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will begin standard-of-care (SOC) immunotherapy for the treatment of cancer at OHSU and Knight Cancer Institute Community Hematology Oncology (CHO) clinics.
Who may be able to join
- 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.)
- 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.)
- 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.)
Who cannot join
- 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.)
- Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
- 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.)
- 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.)
- 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.)
- 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.)
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- Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Deanne Tibbitts, 503-494-4361, tibbitts@ohsu.edu
Deanne Tibbitts
About this study
Official title: INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Characterize sex differences in patient-reported symptomatic immune-related adverse events.
II. Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender.
OUTLINE: This is an observational study.
Patients complete surveys and have their medical records reviewed on study.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients complete surveys and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported symptoms
Will compare the number, severity, and burden of symptoms by sex. Will be assessed using the Patient-Reported Outcomes Common Toxicity Criteria and Adverse Events (PRO-CTCAE) version (v)1.0 reporting tool.
Measured: Baseline, weekly thereafter up to 26 weeks
Patient-reported Quality of Life (QOL) - Part 1
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
Measured: Baseline, month 3, month 6
Patient-reported QOL - Part 2
PROMIS Cognitive Function instruments
Measured: Baseline, month 3, month 6
Patient-reported QOL - Part 3
Selected questions from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 to evaluate the impact of immunotherapy on QOL.
Measured: Baseline, month 3, month 6
Clinician-assessed patient symptoms
Clinicians will rate patient symptoms according to the (National Cancer Institute CTCAE) v5.0 scoring system, which grades adverse events according to 5 categories of severity and requires evaluation of the extent to which the adverse event can be attributed to treatment ("unrelated" to "definite"). Will examine agreement using intraclass correlations by patient gender.
Measured: Baseline, month 3, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Sep 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Deanne Tibbitts, OHSU Knight Cancer Institute
- Investigators
- Deanne Tibbitts, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562777
- Sponsor's protocol ID
- STUDY00025328
- Other IDs
- NCI-2023-06611, STUDY00025328
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)
- ClinicalTrials.gov ID
- NCT06562777
- Acronym / sponsor ID
- STUDY00025328
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.
Detailed description
PRIMARY OBJECTIVES:
- Characterize sex differences in patient-reported symptomatic immune-related adverse events.
II. Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender.
OUTLINE: This is an observational study.
Patients complete surveys and have their medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients complete surveys and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will begin standard-of-care (SOC) immunotherapy for the treatment of cancer at OHSU and Knight Cancer Institute Community Hematology Oncology (CHO) clinics.
Key inclusion criteria (3 listed)
- 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.)
- 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.)
- 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.)
Key exclusion criteria (9 listed)
- 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.)
- Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
- 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.)
- 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.)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Patient-reported symptoms
Time frame: Baseline, weekly thereafter up to 26 weeks
Will compare the number, severity, and burden of symptoms by sex. Will be assessed using the Patient-Reported Outcomes Common Toxicity Criteria and Adverse Events (PRO-CTCAE) version (v)1.0 reporting tool.
Patient-reported Quality of Life (QOL) - Part 1
Time frame: Baseline, month 3, month 6
Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
Patient-reported QOL - Part 2
Time frame: Baseline, month 3, month 6
PROMIS Cognitive Function instruments
Patient-reported QOL - Part 3
Time frame: Baseline, month 3, month 6
Selected questions from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 to evaluate the impact of immunotherapy on QOL.
Clinician-assessed patient symptoms
Time frame: Baseline, month 3, month 6
Clinicians will rate patient symptoms according to the (National Cancer Institute CTCAE) v5.0 scoring system, which grades adverse events according to 5 categories of severity and requires evaluation of the extent to which the adverse event can be attributed to treatment ("unrelated" to "definite"). Will examine agreement using intraclass correlations by patient gender.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deanne Tibbitts principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported symptoms (time frame: Baseline, weekly thereafter up to 26 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.