Registre prospectif de l'histotripsie pour les tumeurs des tissus mous
Histotripsy is a treatment that uses focused ultrasound waves to break down tissue without surgery. The ultrasound waves meet at a specific spot and turn the tissue into liquid. This study is a prospective observational registry of participants receiving histotripsy. The goal of this study is to gather information about the use of histotripsy to confirm it is safe and effective medical procedure.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.
PRIMARY OBJECTIVES:
- Tumor response on imaging will be assessed using standardized criteria for tumor types such as European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST).
- Progression free survival and overall survival.
- Risk factors for adverse events identified by NCI Common Terminology Criteria for Adverse Events (CTCAE).
OUTLINE:
Researchers will collect data from consenting participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
-
-
California
-
San Francisco, California, États-Unis, 94143
- University of California, San Francisco
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult participants diagnosed with soft tissue malignancies receiving care at UCSF who previously received HIFU
La description
CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.
Inclusion Criteria:
- All adult patients who are treated with histotripsy per standard clinical care at University of California San Francisco (UCSF) are eligible for inclusion in the registry.
Exclusion Criteria:
- Children/minors, and adults who lack decision-making capacity, will be excluded from the registry. Patients who do not consent for inclusion in the registry will also be excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Participants with Soft Tissue Tumors
Participant data will be collected from participants' medical records. Cancer history, laboratory analysis, histotripsy procedure details, adverse events, and oncological outcomes of the procedure along with demographic data will be collected. |
Data will be collected from the participants medical records.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Frequency of overall tumor response across all participants
Délai: up to 3 years
|
Imaging studies will be conducted to assess for a response across all participants (complete response (CR), Partial response (PR), Stable Disease (SD) and Progressive disease (PD) etc.) using the standardized criteria for tumor response assessment. The standard criteria for European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST) will be used to determine response depending on the participant's soft tissue tumor type |
up to 3 years
|
|
Proportion of participants experienced an adverse event
Délai: Up to 3 years
|
Proportion of participants with adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). Adverse events will be evaluated using multivariate analysis. |
Up to 3 years
|
|
Progression free survival (PFS)
Délai: up to 3 years
|
The analysis of progression-free survival (PFS) will include all participants who have received histotripsy treatment. PFS is defined as the time from the date of histotripsy treatment to the first documented disease progression or death from any cause, whichever occurs first. PFS will be evaluated using time-to-event analysis methods. |
up to 3 years
|
|
Overall Survival (OS)
Délai: Up to 3 years
|
The analysis of OS include participants who have received histotripsy treatment. OS is defined as the of treatment to the time of death. OS will be evaluated using time-to-event analysis methods. |
Up to 3 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ryan Lokken, MD, University of California, San Francisco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 254513
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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