Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459791
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-27
Brief Title:
Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Organoid
Sponsor:
Institut Curie
Organization:
Institut Curie
Study Overview
Official Title:
Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar Proof-of-concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVATAR
Brief Summary:
A biopsy of a breast tumor lesion will be performed for processing to establish avatars patient-derived organoids -PDO A personalized tumorogram for each patient will be provided based on the results of the drug screening tumor predicted as sensitive intermediate resistant or non-evaluable for each drug tested Patients with an informative tumorogram will receive one of the recommended treatments line N1 in the event of tumor progression administered according to standard procedures and validated at medical meetings specific to each center and their fate will be monitored
Detailed Description:
A biopsy of a breast tumor lesion will be performed and transferred to the LIP laboratory at the Institut Curie Laboratoire dInvestigation Préclinique Département de Recherche Translationnelle for processing to establish avatars patient-derived organoids -PDO
Step 1 Establishment of avatar PDO follow-up of line N standard care when the tumorogram is established then follow-up of standard line N1
The patient will then be treated line N as part of standard care while awaiting the result of the tumorogram
A drug screening will be carried out on the PDO 5-10 drugspatient which will be progressive and adapted to the clinical context including treatment history including drugs used in standard care cf list in Table 1
A personalized tumorogram for each patient will be provided based on the results of the drug screening tumor predicted as sensitive intermediate resistant or non-evaluable for each drug tested
A multidisciplinary committee will be set up for this study which will meet regularly 1 time per week to discuss patients included in the study obtaining PDOs drugs to be prioritized in the screening results of the drug screening and personalized tumorograms The committee will include at least one oncologist and one biologist from the laboratory
The multidisciplinary committee will make a therapeutic recommendation based on the personalized tumorogram which may include several drugs considered sensitive to the tumour
A tumorogram will be considered as informative if it proposes at least one chemotherapy molecule considered as sensitive in the PDO model
Patients whose PDO could not be obtained or whose tumorogram was not informative will receive standard treatment
Step 2 informative tumorogram follow-up of experimental line N1 Patients with an informative tumorogram will receive one of the recommended treatments line N1 in the event of tumor progression administered according to standard procedures and validated at medical meetings specific to each center and their fate will be monitored
Step 1 Establishment of avatar PDO follow-up of line N standard care when the tumorogram is established then follow-up of standard line N1
The patient will then be treated line N as part of standard care while awaiting the result of the tumorogram
A drug screening will be carried out on the PDO 5-10 drugspatient which will be progressive and adapted to the clinical context including treatment history including drugs used in standard care cf list in Table 1
A personalized tumorogram for each patient will be provided based on the results of the drug screening tumor predicted as sensitive intermediate resistant or non-evaluable for each drug tested
A multidisciplinary committee will be set up for this study which will meet regularly 1 time per week to discuss patients included in the study obtaining PDOs drugs to be prioritized in the screening results of the drug screening and personalized tumorograms The committee will include at least one oncologist and one biologist from the laboratory
The multidisciplinary committee will make a therapeutic recommendation based on the personalized tumorogram which may include several drugs considered sensitive to the tumour
A tumorogram will be considered as informative if it proposes at least one chemotherapy molecule considered as sensitive in the PDO model
Patients whose PDO could not be obtained or whose tumorogram was not informative will receive standard treatment
Step 2 informative tumorogram follow-up of experimental line N1 Patients with an informative tumorogram will receive one of the recommended treatments line N1 in the event of tumor progression administered according to standard procedures and validated at medical meetings specific to each center and their fate will be monitored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None