MalignancyIOGNCT04656873
Immuno-Oncology Database and Bioregistry
An observational study of Malignancy and Immune System Diseases, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor cells to hide and easier for the immune system to destroy them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy, Immune System Diseases, Autoimmune Diseases
- What is being tested?
- Biospecimen Collection, Medical Chart Review and Questionnaires/Surveys
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 4 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult cancer patients starting ICI monotherapy or combination therapy at University of North Carolina at Chapel Hill (UNC-CH).
Who may be able to join
- 18 years of age at time of enrollment
- Diagnosis of cancer
- Starting initial ICI therapy or re-starting ICI treatment after a 2-year gap (including off-label use) at UNC-CH using any currently FDA approved ICI's.
Who cannot join
- Prior ICI treatment within the last 2 years, including FDA approved ICIs and those under investigation (clinical trials).
- Known and untreated BSL-2+ communicable diseases (active/untreated latent TB, HIV, etc.) or other active infections.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Lineberger Comprehensive Cancer Center (LCCC) 1937: Immuno-Oncology Database and Bioregistry: Identifying Mechanisms of Autoimmune Diseases in the Era of Cancer Immunotherapy.
Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor cells to hide and easier for the immune system to destroy them. In doing this, oncologists risk "over activation" where immune cells can cause side effects that could affect any part of the body. These are known as immune related adverse events (irAEs). While irAEs are a known risk of ICIs, scientists and doctors do not understand how they develop, who is more likely to get them, and what is the best way to manage them while still getting the anti-tumor effects from ICIs. The aim of this project is to build an infrastructure for researchers to collaborate in clinical, translational, and basic science research focused on understanding and managing immune related adverse events (irAEs). The investigators will collect research data and samples from patients who receive ICI treatment, including when patients might experience immunotherapy side effects, to store for use in future research studies.
Read the detailed description
BACKGROUND
Tumors evolve to evade the body's anti-tumor immune response by targeting cancer cells and downregulating immune pathways. Immune checkpoint inhibitors (ICIs) prevent this tumor evasion by driving the immune system into an "activated state", and upregulating the patient's immune system to destroy tumor cells. While enhancing the immune system disrupts tumor growth, in doing so oncologists risk "over activation" resulting in immune-mediated toxicity known as immune related adverse events (irAEs).
irAEs are an emerging disease entity, affecting many organ systems with diverse clinical presentations similar to known autoimmune diseases, such as systemic lupus erythematosus, inflammatory arthritis, psoriasis, thyroiditis, inflammatory bowel disease, hepatitis, pneumonitis, and myocarditis. The most common presentations of irAEs are dermatologic (rashes), endocrine (hypo/hyper-active thyroid, hypophysitis, adrenal), and gastrointestinal (colitis). However, any organ system can be affected resulting in a wide array of irAEs.
Immunotherapy, especially ICIs, are being increasingly used in a wide variety of cancer therapy and have been found to effectively treat many different types of cancers. ICIs are monoclonal antibodies targeting cytotoxic T-cell lymphocyte antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) pathways. CTLA-4 and PD-1/PD-L1 are involved in deactivating T-cell and attenuating T-cell effector response, respectively. These are already being used to treat a wide range of cancers with several clinical trials currently underway examining response of additional cancer types to current ICIs as well as for developing new ICI treatments. The investigators anticipate that there will be additional immune checkpoint targets in the future given that some are already in clinical trials and the high interest in cancer immunotherapy.
The goal of this project is to collect, curate, and store data and specimens for future studies presented in separate protocols. This patient registry will provide biological specimens for biomarker analysis, immunophenotyping, genetic and microbiome analysis to understand development of autoimmune conditions. Clinical data can be used for epidemiological studies as well as clinical, functional, psychosocial and economic outcomes research regarding impact of ICIs and irAEs on cancer patients. Moreover, this infrastructure can inform the development of clinical algorithms and help determine the effectiveness of medical interventions targeting cancer outcomes and irAEs.
STUDY OUTLINE
Patients will be involved in the study from the time of consent (before starting ICI therapy) until 2 years after the end of ICI treatment. The investigators will collect clinical data (including demographic information, medical history, cancer diagnosis and treatment, management of adverse events, and outcomes), specimens (including blood, urine, stool, biofluids and/or tissue samples), and questionnaires at multiple time points. All patient data and samples will be linked by a de-identified study specific identifier (study ID) and will be stored indefinitely until used or patient withdraw from the study in writing.
STUDY OBJECTIVES
The overall goal of this project is to build an infrastructure that will provide resources for researchers at UNC Chapel Hill and beyond to conduct multidisciplinary clinical, translational, and basic research in elucidating pathways involved in cancer biology and irAEs.
- Conditions
- Malignancy, Immune System Diseases, Autoimmune Diseases
- Being tested
- Biospecimen Collection, Medical Chart Review, Questionnaires/Surveys
- Keywords
- cancer, immunotherapy, immune checkpoint inhibitors, immune related adverse events, autoimmune diseases
- Medical subject headings
- Neoplasms, Immune System Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of cheek swab, blood, urine, stool, and tissue samples for research
Medical Chart ReviewOther
Periodic review of medical records for clinical parameters (labs, ICI dosing and frequency, occurrence, timing and type of irAE, irAE management, etc.) along with relevant demographic information (age, sex/gender, race/ethnicity, insurance type, etc.).
Questionnaires/SurveysOther
Periodic self-report questionnaires/surveys for symptom tracking, quality of life, perinatal outcomes, etc.
| Study group | Role | What they receive |
|---|---|---|
| ICI treatment | Adult cancer patients starting ICI monotherapy or combination therapy at UNC Chapel Hill per clinical standard of care and willing to allow specimens from surplus tissue to be banked for research purposes (in the case of resections) AND willing to have additional specimens taken for research purposes (in the case of biopsies). Patients will be followed for samples and clinical data from medical records from before starting ICI therapy until 2 years after the end of ICI treatment. Receives: Procedure: Biospecimen Collection; Other: Medical Chart Review; Other: Questionnaires/Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Immune Checkpoint Inhibitor Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Clinical database with a linked specimen biorepository from this cohort - including management of irAEs and underlying cancer, irAE and cancer outcomes, surveys (PROs) and specimen collection from various time points during and after treatment.
Measured: Up to 2 years after end of ICI treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start20 May 2021
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Rumey C Ishizawar, MD, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656873
- Sponsor's protocol ID
- LCCC1937
- Other IDs
- 18-0560
- Acronym
- IOG
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2020
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Members of the UNC IOG will review and approve all proposals or similar justifying access to and use of data and/or specimens for ancillary projects and collaborations. Utilizing data or specimens will require a separate IRB application after approval by UNC IOG as well as any contracting necessary for data and material use. To start a request for use of research data and/or specimens, please complete form at the link below.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lineberger Comprehensive Cancer Center (LCCC) 1937: Immuno-Oncology Database and Bioregistry: Identifying Mechanisms of Autoimmune Diseases in the Era of Cancer Immunotherapy.
- ClinicalTrials.gov ID
- NCT04656873
- Acronym / sponsor ID
- IOG / LCCC1937
- Conditions
- Malignancy, Immune System Diseases, Autoimmune Diseases
- Keywords
- cancer, immunotherapy, immune checkpoint inhibitors, immune related adverse events, autoimmune diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, North Carolina Translational and Clinical Sciences Institute
- Study start
- 20 May 2021 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 7 Dec 2020 (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.
Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor cells to hide and easier for the immune system to destroy them. In doing this, oncologists risk "over activation" where immune cells can cause side effects that could affect any part of the body. These are known as immune related adverse events (irAEs). While irAEs are a known risk of ICIs, scientists and doctors do not understand how they develop, who is more likely to get them, and what is the best way to manage them while still getting the anti-tumor effects from ICIs. The aim of this project is to build an infrastructure for researchers to collaborate in clinical, translational, and basic science research focused on understanding and managing immune related adverse events (irAEs). The investigators will collect research data and samples from patients who receive ICI treatment, including when patients might experience immunotherapy side effects, to store for use in future research studies.
Detailed description
BACKGROUND
Tumors evolve to evade the body's anti-tumor immune response by targeting cancer cells and downregulating immune pathways. Immune checkpoint inhibitors (ICIs) prevent this tumor evasion by driving the immune system into an "activated state", and upregulating the patient's immune system to destroy tumor cells. While enhancing the immune system disrupts tumor growth, in doing so oncologists risk "over activation" resulting in immune-mediated toxicity known as immune related adverse events (irAEs).
irAEs are an emerging disease entity, affecting many organ systems with diverse clinical presentations similar to known autoimmune diseases, such as systemic lupus erythematosus, inflammatory arthritis, psoriasis, thyroiditis, inflammatory bowel disease, hepatitis, pneumonitis, and myocarditis. The most common presentations of irAEs are dermatologic (rashes), endocrine (hypo/hyper-active thyroid, hypophysitis, adrenal), and gastrointestinal (colitis). However, any organ system can be affected resulting in a wide array of irAEs.
Immunotherapy, especially ICIs, are being increasingly used in a wide variety of cancer therapy and have been found to effectively treat many different types of cancers. ICIs are monoclonal antibodies targeting cytotoxic T-cell lymphocyte antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) pathways. CTLA-4 and PD-1/PD-L1 are involved in deactivating T-cell and attenuating T-cell effector response, respectively. These are already being used to treat a wide range of cancers with several clinical trials currently underway examining response of additional cancer types to current ICIs as well as for developing new ICI treatments. The investigators anticipate that there will be additional immune checkpoint targets in the future given that some are already in clinical trials and the high interest in cancer immunotherapy.
The goal of this project is to collect, curate, and store data and specimens for future studies presented in separate protocols. This patient registry will provide biological specimens for biomarker analysis, immunophenotyping, genetic and microbiome analysis to understand development of autoimmune conditions. Clinical data can be used for epidemiological studies as well as clinical, functional, psychosocial and economic outcomes research regarding impact of ICIs and irAEs on cancer patients. Moreover, this infrastructure can inform the development of clinical algorithms and help determine the effectiveness of medical interventions targeting cancer outcomes and irAEs.
STUDY OUTLINE
Patients will be involved in the study from the time of consent (before starting ICI therapy) until 2 years after the end of ICI treatment. The investigators will collect clinical data (including demographic information, medical history, cancer diagnosis and treatment, management of adverse events, and outcomes), specimens (including blood, urine, stool, biofluids and/or tissue samples), and questionnaires at multiple time points. All patient data and samples will be linked by a de-identified study specific identifier (study ID) and will be stored indefinitely until used or patient withdraw from the study in writing.
STUDY OBJECTIVES
The overall goal of this project is to build an infrastructure that will provide resources for researchers at UNC Chapel Hill and beyond to conduct multidisciplinary clinical, translational, and basic research in elucidating pathways involved in cancer biology and irAEs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICI treatment | – | Procedure: Biospecimen Collection, Other: Medical Chart Review, Other: Questionnaires/SurveysAdult cancer patients starting ICI monotherapy or combination therapy at UNC Chapel Hill per clinical standard of care and willing to allow specimens from surplus tissue to be banked for research purposes (in the case of resections) AND willing to have additional specimens taken for research purposes (in the case of biopsies). Patients will be followed for samples and clinical data from medical records from before starting ICI therapy until 2 years after the end of ICI treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients starting ICI monotherapy or combination therapy at University of North Carolina at Chapel Hill (UNC-CH).
Key inclusion criteria (3 listed)
- 18 years of age at time of enrollment
- Diagnosis of cancer
- Starting initial ICI therapy or re-starting ICI treatment after a 2-year gap (including off-label use) at UNC-CH using any currently FDA approved ICI's.
Key exclusion criteria (2 listed)
- Prior ICI treatment within the last 2 years, including FDA approved ICIs and those under investigation (clinical trials).
- Known and untreated BSL-2+ communicable diseases (active/untreated latent TB, HIV, etc.) or other active infections.
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of cheek swab, blood, urine, stool, and tissue samples for research | Procedure or surgery | ICI treatment |
| Medical Chart ReviewPeriodic review of medical records for clinical parameters (labs, ICI dosing and frequency, occurrence, timing and type of irAE, irAE management, etc.) along with relevant demographic information (age, sex/gender, race/ethnicity, insurance type, etc.). | Other | ICI treatment |
| Questionnaires/SurveysPeriodic self-report questionnaires/surveys for symptom tracking, quality of life, perinatal outcomes, etc. | Other | ICI treatment |
Primary outcome
Number of Participants With Immune Checkpoint Inhibitor Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to 2 years after end of ICI treatment
Clinical database with a linked specimen biorepository from this cohort - including management of irAEs and underlying cancer, irAE and cancer outcomes, surveys (PROs) and specimen collection from various time points during and after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Members of the UNC IOG will review and approve all proposals or similar justifying access to and use of data and/or specimens for ancillary projects and collaborations. Utilizing data or specimens will require a separate IRB application after approval by UNC IOG as well as any contracting necessary for data and material use. To start a request for use of research data and/or specimens, please complete form at the link below.
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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. This study is not recruiting at the moment.
Rumey C Ishizawar, MD, PhD principal investigator
UNC Chapel Hill
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 Malignancy and Immune System Diseases, run by UNC Lineberger Comprehensive Cancer Center 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 2 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: finished, as of the sponsor's last update on 8 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Immune Checkpoint Inhibitor Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: Up to 2 years after end of ICI treatment). 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 Jul 2026.