- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05230186
A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Laurie Barefoot, APRN
- Número de teléfono: 857-399-9930
- Correo electrónico: Lbarefoot@tscan.com
Copia de seguridad de contactos de estudio
- Nombre: Shrikanta Chattopadhyay, MD
- Número de teléfono: 857-399-9472
- Correo electrónico: Schattopadhyay@tscan.com
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
- Reclutamiento
- USC Norris Comprehensive Cancer Center
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Contacto:
- Xiomara Menendez, RN,
- Número de teléfono: 323-865-0212
- Correo electrónico: Xiomara.menendez@med.usc.edu
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70124
- Reclutamiento
- Ochsner Clinic Foundation
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Investigador principal:
- Marc Matrana, MD
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Contacto:
- Donnalee Trapani, CCRP, CRC
- Número de teléfono: 504-865-0212
- Correo electrónico: dtrapani@ochsner.org
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Contacto:
- Rafael Velasquezvalle, Sr. CRC
- Número de teléfono: 504-842-8170
- Correo electrónico: Rafael.velasquezvalle@ochsner.org
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Sub-Investigador:
- Lyndsey Buckner Baiamonte, Ph.D
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Reclutamiento
- Atlantic Health System
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Investigador principal:
- Eric Whitman, MD
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Contacto:
- Maureen Nowakowski, RN
- Número de teléfono: 973-971-7111
- Correo electrónico: Maureen.nowakowski@atlantichealth.org
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New York
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New York, New York, Estados Unidos, 10013
- Reclutamiento
- Advanced Oncology PC
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Contacto:
- Kin Lam, MD
- Número de teléfono: 212-941-9020
- Correo electrónico: kin.lam@rendrcare.com
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Contacto:
- Isabel Wong, RN
- Número de teléfono: 212-941-9020
- Correo electrónico: isabelwong2@gmail.com
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Investigador principal:
- Kin Lam, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo, Cohort 5: Post-Treatment Responder (Frozen)
- Study Cohorts 1,2,3 and 5: Known or suspected diagnosis of non-hematological malignancy.
- Age 18 years at time of diagnosis.
- Research Biopsy Study Cohorts 1 and 2: ECOG performance status 0-2.
- Ability to understand and willingness to sign an informed consent document.
- Research Biopsy Study Cohorts 1,2,3 and 5: Patients must be eligible for or currently receiving treatment with immune checkpoint inhibitor (ICI) therapy as determined by the patient's treating oncologist. The treatment regimen may comprise more than one agent but must include at least one ICI drug. Examples of FDA-approved ICI drugs include pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq), avelumab (Bavencio), durvalumab (Imfinzi), cemiplimab (Libtayo), and ipilimumab (Yervoy). Immune-checkpoint inhibitors not on this list may also be used, provided they are FDA-approved.
- Research Biopsy Study Cohorts 1,2,3 and 5: Patients undergoing an on-treatment biopsy must show radiographic regression of one or more lesion, as assessed by the investigator.
- Research Biopsy Study Cohorts 1 and 2: Patients undergoing an on-treatment biopsy must have a cancer lesion that is amenable for biopsy under local anesthesia or moderate sedation per standard procedures. The tumor biopsy must have an acceptable clinical risk, as judged by the investigator.
- Research Biopsy Study Cohorts 1,2,4: Platelet count >50,000 prior to biopsy or per the service performing the biopsy.
- Research Biopsy Study Cohorts 1,2,4: Absolute neutrophil count >1500.
- Research Biopsy Study Cohorts 1,2,4: Must be able to safely hold anticoagulants for 5 days prior to biopsy.
- Research Biopsy Study Cohorts 1,2,4: Not receiving therapeutic anticoagulation at the time of the biopsy. Patients on therapeutic anticoagulation must be able to safely hold anticoagulation for the procedure with an acceptable risk, as judged by the investigator. Patients who are on anticoagulation for clinical reasons and deemed appropriate for biopsy must be OFF anticoagulation prior to biopsy as follows:
i. No warfarin (Coumadin) for 5 days. No low-molecular weight heparin (LMWH; e.g. dalteparin/ Fragmin, enoxaparin/ Lovenox) for 24 hours.
ii. No fondaparinux/ Arixtra for 48 hours. iii. Patients receiving alternative forms of anticoagulation not listed above (e.g., dabigatran, rivaroxaban, apixaban, edoxaban) should consult with the prescribing physician and the service performing the biopsy regarding safety and administration guidelines prior to biopsy. Bleeding risks with these agents should be considered when deciding on whether to perform the biopsy if for research purposes only.
Exclusion Criteria:
Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo, Cohort 5: Post-Treatment Responder (Frozen)
- Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with safety.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Research Biopsy Study Cohorts 1,2,4: History of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
- Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of moderate sedation, which is required for biopsies of certain anatomic sites (e.g., liver, lung, bone). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.
- Research Biopsy Study Cohorts 1,2,4: Active cardiac disease, defined as:
i. Uncontrolled or symptomatic angina within the past 3 months. ii. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.
iii. Myocardial infarction < 6 months from study entry. iv. Uncontrolled or symptomatic congestive heart failure. f. Any other condition, which in the opinion of the patient's treating oncologist or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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On-Treatment Solid Tumor Responder (Tumor Biopsy)
Research tumor tissue biopsy collected at any one time point while responding to ICI therapy (radiographic regression of lesion).
Tumor biopsy and companion blood sample.
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Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
Otros nombres:
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Pre and On-Treatment Solid Tumor Responder (Tumor Biopsy)
Tumor tissue collection prior to beginning ICI therapy (optional biopsy).
If and when there is a response to ICI therapy, a second research tumor tissue biopsy is collected.
Tumor biopsy and companion blood sample.
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Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
Otros nombres:
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On-Treatment Solid Tumor Responder (Surgical Removal Tumor)
Collection of excess tumor tissue in patients who are responding to ICI therapy and are scheduled for Surgical resection of residual disease.
Excess tissue provided.
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Post-Treatment of patients with Melanoma who develop vitiligo
Up to 5 patients treated for melanoma that develop vitiligo - Skin Tissue Biopsy obtained at any point in time from any skin site with vitiligo (selected sites only).
Tissue biopsy
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Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
Otros nombres:
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On-Treatment Responder (Previously Frozen Tumor Tissue)
Previously Cryopreserved Tissue obtained from a Biobank or Tissue Repository, collected from patients when they were responding to ICI Therapy (clinical data required).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Single Cell Sequencing
Periodo de tiempo: 3 years
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Determine, through single-cell sequencing, the TCR repertoire of these tumor and blood samples to identify new targets.
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3 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 200-04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tumor Sólido, Adulto
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Aadi Bioscience, Inc.ReclutamientoTumor sólido avanzado | Tumor | Tumor SólidoEstados Unidos
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Sorrento Therapeutics, Inc.RetiradoTumor solido | Tumor sólido en recaída | Tumor refractario
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Memorial Sloan Kettering Cancer CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
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RemeGen Co., Ltd.TerminadoTumor sólido metastásico | Tumor sólido localmente avanzado | Tumor sólido irresecableAustralia
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Baodong QinReclutamientoTumor refractario | Tumor raroPorcelana
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalReclutamiento
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.ReclutamientoNeoplasias | Tumor solido | Tumor malignoPorcelana
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyReclutamientoTumor Sólido, Adulto | Tumor refractarioEstados Unidos
Ensayos clínicos sobre Tumor Biopsy
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Aquyre Bioscience, IncBoston University; Fox Chase Cancer Center; Johnson & JohnsonReclutamiento
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University Hospital, Basel, SwitzerlandTerminadoBiopsia de Médula ÓseaSuiza
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Cliniques universitaires Saint-Luc- Université...Université de LiègeReclutamientoFibrosis quística | BiomarcadoresBélgica
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Samsung Medical CenterDesconocido
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Emory UniversityTerminadoCáncer de mama | Neoplasias de mama | Tumores de mama | Neoplasias De Mama | Cáncer de mama | Cáncer de mama | Carcinoma mamario humanoEstados Unidos
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Shanghai General Hospital, Shanghai Jiao Tong University...Desconocido
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Aga Khan UniversityDesconocidoEnfermedades o condiciones musculoesqueléticasPakistán
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European Institute of OncologyReclutamiento
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Ottawa Hospital Research InstituteDesconocido
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Jewish General HospitalLaurentian UniversityTerminado