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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Bene-Atarot, 이스라엘, 60991
- 모병
- Optimata Ltd.
-
연락하다:
- Marina Kleiman, PhD
- 전화번호: 112 972-751-9226
- 이메일: marina@optimata.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
The primary endpoint in this study stage is Time to Progression of disease
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Marina Kleiman, PhD, Optimata Ltd.
- 수석 연구원: Michal Lotem, MD, Hadassah Medical Organization
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OPTI-007
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .