Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482086
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-15
Brief Title:
Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Precision Medicine Applied to Locally Advanced Thyroid Cancer Using Tumor-derived Organoids and In-vitro Sensitivity Testing a Phase 2a Single-center Open-label and Non-comparative Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients
Detailed Description:
This research trial aims to determine the efficacy of organoid-guided targeted therapy for patients with locally advanced thyroid cancer We will also investigate the variables affecting the effectiveness of targeted therapy for locally advanced thyroid cancer that is guided by organoids Additionally side effects related to the medication are also studied
The following are the main questions that the trial seeks to address
Can patients tumor sizes be shrunk by taking medications that were found to be sensitive by organoid screening Can patients survival outcomes be improved by the medications that organoid screening found as sensitive What aspects of the medications shown to be responsive by organoid screening are impacting their clinical efficacy Is it possible for organoid-based drugs screening to guide treatment which lower surgical risk and make cancers that are now incurable into manageable ones To ascertain the efficacy of the screened sensitive drugs in treating locally advanced thyroid cancer researchers will measure the tumor size before and after taking the organoid-screened sensitive targeted drugs assess the risk of radical resection and document the survival outcomes of enrolled patients
To further elucidate the parameters impacting the efficacy and prognosis prognostic analysis based on clinical and pathological data such as pathological type gene mutation age tumor size distant metastasis and involvement of the trachea esophagus or major artery will also be conducted
The sample size for this study was determined based on the objective response rate ORR observed in our preliminary pilot study which indicated an ORR of 22 For papillary thyroid carcinoma PTC follicular thyroid carcinoma FTC and poorly differentiated thyroid carcinoma PDTC we aimed to detect a treatment effect with a minimum ORR of 12 consistent with results from the previous multicenter randomized double-blind placebo-controlled phase 3 trial DECISION For anaplastic thyroid carcinoma ATC and medullary thyroid carcinoma MTC we aimed to detect a treatment effect with a minimum ORR of 1 considered the threshold for clinical efficacy
To achieve a one-sided 95 confidence interval α 005 the Clopper-Pearson method was used to calculate the confidence interval for a proportion This method ensured that the lower bound of the 95 confidence interval would exceed the minimum ORR 12 for PTC FTC and PDTC 1 for ATC and MTC
The calculation indicated that a total of 42 samples are needed for PTC FTC and PDTC while 5 samples are required for both MTC and ATC
Considering a 10 dropout rate and an 80 success rate for organoid drug sensitivity tests a total of 59 samples are needed for PTC FTC and PDTC while 7 samples are required for both MTC and ATC
The following are the main questions that the trial seeks to address
Can patients tumor sizes be shrunk by taking medications that were found to be sensitive by organoid screening Can patients survival outcomes be improved by the medications that organoid screening found as sensitive What aspects of the medications shown to be responsive by organoid screening are impacting their clinical efficacy Is it possible for organoid-based drugs screening to guide treatment which lower surgical risk and make cancers that are now incurable into manageable ones To ascertain the efficacy of the screened sensitive drugs in treating locally advanced thyroid cancer researchers will measure the tumor size before and after taking the organoid-screened sensitive targeted drugs assess the risk of radical resection and document the survival outcomes of enrolled patients
To further elucidate the parameters impacting the efficacy and prognosis prognostic analysis based on clinical and pathological data such as pathological type gene mutation age tumor size distant metastasis and involvement of the trachea esophagus or major artery will also be conducted
The sample size for this study was determined based on the objective response rate ORR observed in our preliminary pilot study which indicated an ORR of 22 For papillary thyroid carcinoma PTC follicular thyroid carcinoma FTC and poorly differentiated thyroid carcinoma PDTC we aimed to detect a treatment effect with a minimum ORR of 12 consistent with results from the previous multicenter randomized double-blind placebo-controlled phase 3 trial DECISION For anaplastic thyroid carcinoma ATC and medullary thyroid carcinoma MTC we aimed to detect a treatment effect with a minimum ORR of 1 considered the threshold for clinical efficacy
To achieve a one-sided 95 confidence interval α 005 the Clopper-Pearson method was used to calculate the confidence interval for a proportion This method ensured that the lower bound of the 95 confidence interval would exceed the minimum ORR 12 for PTC FTC and PDTC 1 for ATC and MTC
The calculation indicated that a total of 42 samples are needed for PTC FTC and PDTC while 5 samples are required for both MTC and ATC
Considering a 10 dropout rate and an 80 success rate for organoid drug sensitivity tests a total of 59 samples are needed for PTC FTC and PDTC while 7 samples are required for both MTC and ATC
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