Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 2:53 PM
Study NCT ID:
NCT05424692
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2022-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined with Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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 research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.
Detailed Description:
The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 \~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience. All exon (WES) data collection was used to predict postoperative survival in both groups.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C \>- Δ
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience. All exon (WES) data collection was used to predict postoperative survival in both groups.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C \>- Δ
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: