Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy
Multi-centre, Retrospective, Open Label Study, to Establish and Validate ML-PrediCare for Patients of Advanced Melanoma Undergoing Immunotherapy, as a 1st, 2nd and Later Lines
Aperçu de l'étude
Description détaillée
The aim of this project is to develop a technology application (termed ML-PrediCare), which is meant to be a predictive stand-alone software device, to support clinicians' decision-making, by predicting the individual patient's response to immunotherapy treatments, e.g., in terms of time-to-progression (TTP).
In Stage I of the study, data will be collected for establishing a training set and assess the predictive potential of the modelling technology for the response of melanoma patients to immunotherapy. In Stage II of the study, data will be collected in order to establish a validation set and test the predictive power of the modelling technology in an independent set of patients diagnosed with melanoma.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Bene-Atarot, Israël, 60991
- Recrutement
- Optimata Ltd.
-
Contact:
- Marina Kleiman, PhD
- Numéro de téléphone: 112 972-751-9226
- E-mail: marina@optimata.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Patients who meet all of the following criteria are eligible for this study:
- Gender: Female, Male.
- Age: Eighteen years and older at the start of treatment.
- Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
- Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
- Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
- Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.
- Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for melanoma.
Exclusion Criteria:
Patients meeting one or more of the following criteria are ineligible for this study:
History of another malignancy within the previous 2 years except for:
• Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
- Ocular melanoma
- Active brain metastases or leptomeningeal metastases.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Training Set
The objective of the Training stage is to assess the predictive potential of ML-PrediCare for melanoma patients' response to Ipilimumab, Pembrolizumab and Nivolumab.
|
|
|
Validation Set
The objective of the Validation stage is to test the predictive power of ML -PrediCare in an independent set of patients diagnosed with melanoma.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
The primary endpoint in this study stage is Time to Progression of disease
Délai: 1 year
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Marina Kleiman, PhD, Optimata Ltd.
- Chercheur principal: Michal Lotem, MD, Hadassah Medical Organization
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OPTI-007
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .