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- Klinische proef NCT05230186
A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Laurie Barefoot, APRN
- Telefoonnummer: 857-399-9930
- E-mail: Lbarefoot@tscan.com
Studie Contact Back-up
- Naam: Shrikanta Chattopadhyay, MD
- Telefoonnummer: 857-399-9472
- E-mail: Schattopadhyay@tscan.com
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90033
- Werving
- USC Norris Comprehensive Cancer Center
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Contact:
- Xiomara Menendez, RN,
- Telefoonnummer: 323-865-0212
- E-mail: Xiomara.menendez@med.usc.edu
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70124
- Werving
- Ochsner Clinic Foundation
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Hoofdonderzoeker:
- Marc Matrana, MD
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Contact:
- Donnalee Trapani, CCRP, CRC
- Telefoonnummer: 504-865-0212
- E-mail: dtrapani@ochsner.org
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Contact:
- Rafael Velasquezvalle, Sr. CRC
- Telefoonnummer: 504-842-8170
- E-mail: Rafael.velasquezvalle@ochsner.org
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Onderonderzoeker:
- Lyndsey Buckner Baiamonte, Ph.D
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New Jersey
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Morristown, New Jersey, Verenigde Staten, 07960
- Werving
- Atlantic Health System
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Hoofdonderzoeker:
- Eric Whitman, MD
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Contact:
- Maureen Nowakowski, RN
- Telefoonnummer: 973-971-7111
- E-mail: Maureen.nowakowski@atlantichealth.org
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New York
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New York, New York, Verenigde Staten, 10013
- Werving
- Advanced Oncology PC
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Contact:
- Kin Lam, MD
- Telefoonnummer: 212-941-9020
- E-mail: kin.lam@rendrcare.com
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Contact:
- Isabel Wong, RN
- Telefoonnummer: 212-941-9020
- E-mail: isabelwong2@gmail.com
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Hoofdonderzoeker:
- Kin Lam, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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.
Andere namen:
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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.
Andere namen:
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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.
Andere namen:
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Single Cell Sequencing
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 200-04
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Vaste tumor, volwassen
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St. Boniface HospitalHeart and Stroke Foundation of CanadaWervingVoeding slecht | Cardiovasculaire morbiditeit | Frail Older Adult SyndroomCanada
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Sorrento Therapeutics, Inc.IngetrokkenVaste tumor | Recidiverende vaste tumor | Refractaire tumor
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Aadi Bioscience, Inc.WervingGeavanceerde vaste tumor | Tumor | Tumor, solideVerenigde Staten
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Memorial Sloan Kettering Cancer CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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RemeGen Co., Ltd.VoltooidMetastatische vaste tumor | Lokaal geavanceerde vaste tumor | Inoperabele vaste tumorAustralië
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalWerving
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.WervingNeoplasmata | Vaste tumor | Kwaadaardige tumorChina
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The First Affiliated Hospital of Xiamen UniversityWervingVaste tumor | Tumor | Positron-emissietomografieChina
Klinische onderzoeken op Tumor Biopsy
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Aquyre Bioscience, IncBoston University; Fox Chase Cancer Center; Johnson & JohnsonWerving
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City of Hope Medical CenterNational Cancer Institute (NCI)VoltooidGenito-urine neoplasmaVerenigde Staten
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NeoDynamics ABWervingBorstkankerVerenigd Koninkrijk
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Cliniques universitaires Saint-Luc- Université...Université de LiègeWervingTaaislijmziekte | BiomarkersBelgië
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Weill Medical College of Cornell UniversityBeëindigd
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Owlstone LtdCambridge University Hospitals NHS Foundation TrustVoltooidCOVIDVerenigd Koninkrijk
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Owlstone LtdMaastricht University; OLVGVoltooid
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The Netherlands Cancer InstituteJohns Hopkins University; Catharina Ziekenhuis Eindhoven; Amsterdam UMC, location... en andere medewerkersWervingOvariumneoplasmataNederland
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Emory UniversityVoltooidBorstkanker | Borstneoplasmata | Borst tumoren | Neoplasmata, borst | Borstkanker | Kanker van de borst | Borstkanker bij de mensVerenigde Staten
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Ulrik LassenWervingNiet-gespecificeerde volwassen solide tumor, protocolspecifiekDenemarken