Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-18 @ 8:28 AM
Study NCT ID:
NCT05267912
Status:
None
Last Update Posted:
2025-12-16 00:00:00
First Post:
2022-02-09 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Study Evaluating Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers
Sponsor:
None
Organization:
Study Overview
Official Title:
Prospective Multicenter Study Evaluating the Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers
Status:
None
Status Verified Date:
2025-12
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:
ORGANOTREAT
Brief Summary:
ORGANOTREAT-01, -02A and -02B
* Patients with advanced, pretreated solid cancers will be enrolled at the beginning of a standard-of-care (SoC) treatment line to allow sufficient time for PDO (tumor-derived organoid) generation and chemogram.
* A biopsy of an easily accessible tumor site will be performed.
* PDO generation, culture and amplification and drug testing will be performed.
* A chemogram report will be prepared.
* The CTB (Chemogram Tumor Board) will make treatment recommendations based on the chemogram report.
* Patients enrolled in ORGANOTREAT-01, ORGANOTREAT-02A and in the experimental arm of ORGANOTREAT-02B will be treated according to the CTB's recommendations after disease progression or unacceptable toxicity while on SoC.
* Patients will be treated at the investigator's discretion until disease progression or unacceptable toxicities. Patient will be followed until death or study termination, whichever occurs first . Note : Provide, as long as necessary (without time limit) the treatments to patient is agreed by all the centers.
* Patients for whom no chemogram can be obtained will be treated according to Soc
* Patients with advanced, pretreated solid cancers will be enrolled at the beginning of a standard-of-care (SoC) treatment line to allow sufficient time for PDO (tumor-derived organoid) generation and chemogram.
* A biopsy of an easily accessible tumor site will be performed.
* PDO generation, culture and amplification and drug testing will be performed.
* A chemogram report will be prepared.
* The CTB (Chemogram Tumor Board) will make treatment recommendations based on the chemogram report.
* Patients enrolled in ORGANOTREAT-01, ORGANOTREAT-02A and in the experimental arm of ORGANOTREAT-02B will be treated according to the CTB's recommendations after disease progression or unacceptable toxicity while on SoC.
* Patients will be treated at the investigator's discretion until disease progression or unacceptable toxicities. Patient will be followed until death or study termination, whichever occurs first . Note : Provide, as long as necessary (without time limit) the treatments to patient is agreed by all the centers.
* Patients for whom no chemogram can be obtained will be treated according to Soc
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: