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Trial Title:
Development of Tumor Organoids from Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions
NCT ID:
NCT06612827
Condition:
Undifferentiated Carcinoma
Conditions: Official terms:
Carcinoma
Conditions: Keywords:
tumoroid
organoid
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
organoid etablishment
Description:
Prior to initiation of 1st-line therapy:
- Collection of an additional study-specific tumor sample for tumoroid analysis (1
fresh tumor sample)
- A blood test blood a for tumoroid realization and :
- Analysis of ex vivo tumoroid response to treatment and correlation with patient
response in vivo
- Analysis of correlation between in vivo and ex vivo tumor characteristics
- Analysis of first- and second-line survival rates and overall survival
Arm group label:
Blood and tumor collection
Summary:
The study is based on the constitution of a collection of tumor and blood samples for the
development of tumoroid for functional tests to predict clinical response to treatment.
Criteria for eligibility:
Study pop:
Patient with undifferentiated primary carcinoma (UPC) with indication for 1st-line
treatment
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patient with undifferentiated primary carcinoma (UPC) with histological and
immunohistochemical evidence, validated in a local and/or national UPC
multidisciplinary consultation
- Patient with indication for 1st-line treatment at the time of inclusion.
- Patient with life expectancy greater than 3 months
- Patient of legal age
- Patient affiliated to a social security scheme
- Signature of informed consent prior to any specific study procedure
Exclusion Criteria:
- Persons deprived of their liberty or under guardianship (including curatorship)
- Pregnant or breast-feeding patient
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Country:
France
Contact:
Last name:
Zoé NEVIERE, MD
Phone:
33231455050
Email:
z.neviere@baclesse.unicancer.fr
Start date:
December 15, 2024
Completion date:
December 15, 2031
Lead sponsor:
Agency:
Centre Francois Baclesse
Agency class:
Other
Source:
Centre Francois Baclesse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06612827
