Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Age ≥ 18 years old. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 3. Female or Male. 4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3). Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program. Seven cohorts of subjects are defined in this prospective multicenter study:
- - Cohort 1: Triple negative breast cancer (TNBC) - Cohort 2: HER 2 positive breast cancer (HER2+ BC) - Cohort 3: Non-small cell lung cancer (NSCLC) - Cohort 4: Small cell lung cancer (SCLC) - Cohort 5: Melanoma.
- - Cohort 6: Other solid tumours (apart from the above mentioned subtypes.
- - Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis.
Exclusion Criteria:1. Pregnant and/or lactating women. 2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin. 3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study. Exclusion criterion applicable to FRANCE only. 4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Jules Bordet Institute|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Nuria Kotecki, MD|
|Principal Investigator Affiliation||Jules Bordet Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, France, Luxembourg|
The disease, disorder, syndrome, illness, or injury that is being studied.
Other: CNS metastases from solid tumours
The study will be organised on three time-periods based on the time of the 1st CNS event: Part A - Pre-diagnosis period: before diagnosis of the 1st CNS event Part B - At 1st CNS diagnosis period Part C - Post diagnosis period: after the 1st CNS event
Other: - Samples collection: Plasma
At baseline Part A: TNBC/ HER2+ BC: once a year NSCLC/SCLC: every 4 months Melanoma: every 6 months Part B: o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: o Every 3 months (+/- 1 month)
Other: - Samples collection: CSF
Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice
Other: - Samples collection: Non-CNS Metastatic Tumour Tissue
Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
Other: - Brain MRI
Part A: Brain MRI at inclusion is allowed within 45 days before enrolment Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month) Part B: o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)
Other: - Samples collection: Serum
At baseline Part A: TNBC/ HER2+ BC: once a year NSCLC/SCLC: every 4 months Melanoma: every 6 months Part B: o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.