Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615830
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Organoid-driven Chemotherapy Choice in Metastatic Pancreatic Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-centre Phase 2 Open Label Two Independent Arms Study Assessing Organoid-driven Tumoral Chemosensitivity in Metastatic Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pancreatic cancer is burdened by an extremely low survival rate Survival chances reduce even further when the tumor spreads to other organs such as lymphnodes liver or lungs When the tumor cannot be surgically resected the only valid curative option is represented by chemotherapy However therapies available to date have limited efficacy and they do not specifically target the biological characteristics of the tumor The aim of the project is to validate a new technology called amp34patient-derived organoidsamp34 PDOs in predicting the best drugs for the treatment of pancreatic cancer based on the tumoral characteristics and behavior
In order to generate PDOs a sample of tumoral tissue will be collected during a small surgical procedure called laparoscopy PDOs represent mini three-dimensional copies of the original tumor of which they maintain its behavior and aggressiveness Through the DNA and RNA analysis of the tumor the aim is to predict the best available drug by screening thousands of potentially effective compounds Once identified drugs will be tested in vitro on PDOs and the most efficient drug in controlling the tumor will be administered to the patient once the present standard-of-care treatments fail
Multiple benefits are expected from this trial First of all the most effective drug against their tumor based on an objective in vitro response will be provided This might reflect in a better control of the disease and in a longer survival Targeting the chemotherapy will also imply less side-effects due to unnecessary elevated chemotherapeutic dosages which in turn will lead to a better compliance with the therapy Eventually all these aspects will reflect into a better quality of life
In order to generate PDOs a sample of tumoral tissue will be collected during a small surgical procedure called laparoscopy PDOs represent mini three-dimensional copies of the original tumor of which they maintain its behavior and aggressiveness Through the DNA and RNA analysis of the tumor the aim is to predict the best available drug by screening thousands of potentially effective compounds Once identified drugs will be tested in vitro on PDOs and the most efficient drug in controlling the tumor will be administered to the patient once the present standard-of-care treatments fail
Multiple benefits are expected from this trial First of all the most effective drug against their tumor based on an objective in vitro response will be provided This might reflect in a better control of the disease and in a longer survival Targeting the chemotherapy will also imply less side-effects due to unnecessary elevated chemotherapeutic dosages which in turn will lead to a better compliance with the therapy Eventually all these aspects will reflect into a better quality of life
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?:
None