Clinical trial · Observational
Serial Testing To Assess Cognitive Function In Cancer
Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy
NCT06160700CI-TRIAL-00077827terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): loss of research support
Summary
Brief summary (as posted)
The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Montreal Cognitive Assessment (MoCA) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Immunotherapy Only
- description
- Subjects who are currently receiving immunotherapy only.
- interventionNames
- Behavioral: Montreal Cognitive Assessment (MoCA)
- label
- Chemo-Immunotherapy Control Arm
- description
- Subjects who are receiving chemo-immunotherapy.
- interventionNames
- Behavioral: Montreal Cognitive Assessment (MoCA)
- label
- No Active Therapy Control Arm
- description
- Subjects who are no currently receiving active therapy.
- interventionNames
- Behavioral: Montreal Cognitive Assessment (MoCA)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Immunotherapy Only Group: 1. Age ≥ 18 years old 2. Ability to provide written informed consent and HIPAA authorization. 3. Patients with any type or stage of cancer eligible to begin treatment with immunotherapy alone. Note: Prior radiation therapy if not to the brain is acceptable. Inclusion Criteria for Chemotherapy plus Immunotherapy Control Arm: 1. Age ≥ 18 years old 2. Ability to provide written informed consent and HIPAA authorization. 3. Patients with any stage of cancer eligible to begin treatment with chemoimmunotherapy. Note: Prior radiation therapy if not to the brain is acceptable. Note: Patients receiving chemotherapy followed by immunotherapy between baseline and the 3 months MoCA will be eligible. Inclusion Criteria for Patients not on Active Treatment Control Arm: 1. Age ≥ 18 years old 2. Ability to provide written informed consent and HIPAA authorization. 3. Patients with a prior history of cancer treated with surgery alone at least 1 year out of treatment OR surgery and neo-adjuvant/adjuvant chemotherapy who are at least 2 years out from treatment. If patients underwent any other form of treatment for their current malignancy, they will be excluded. Note: Prior radiation therapy if not to the brain is acceptable. Exclusion Criteria: 1. Patients who screen positive for depression by PHQ-2 test defined as a score more than 3 will complete the PHQ-9 questionnaire. If they screen positive for depression on the PHQ-9 questionnaire (score of 10 or more) or refuse to complete it, they will be excluded. 2. Patients with a history of prior malignancy (excluding skin squamous cell or basal cell cancers). 3. Patients with history of brain radiation and brain metastasis. 4. Patients with a known prior diagnosis of cognitive dysfunction such as dementia from either Alzheimer's, vascular dementia, Parkinson's, mental retardation, head injury etc. Or any uncontrolled etiologies that can affect cognitive function such as anxiety, depression, bipolar disorder, schizophrenia and hypo/hyperthyroidism will be excluded. Note: patients with controlled anxiety/ depression who don't screen positive on the PHQ-2 scale are eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.