Status:
UNKNOWN
Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology
Lead Sponsor:
WeiWei Xiao
Collaborating Sponsors:
Haplox Biotechnology Co., Ltd.
Conditions:
Rectal Adenocarcinoma
Circulating Tumor DNA
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to study the performance of MRD monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore the value of MRD ...
Detailed Description
This study is a prospective, observational study. It is expected to enroll 50 patients with newly diagnosed stage II-III rectal cancer.Before neoadjuvant chemoradiotherapy, tumor tissue will be collec...
Eligibility Criteria
Inclusion
- Age 18-75
- Rectal adenocarcinoma confirmed by pathology
- The clinical stage is II-III.
- Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose to wait for observation ).
- ECOG 0-1;
- No distant metastasis ;
- Main organ function is normal ;
- signed informed consent and willing to accept long-term follow-up；
- No anti-tumor treatment was received within 4 weeks before baseline sampling ;
- Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization, and sufficient whole blood samples need to be provided for baseline MRD detection.
- \-
Exclusion
- unable to provide sufficient tissue / blood samples to meet the research needs ;
- received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ;
- Patients did not receive neoadjuvant therapy according to the original plan ;
- Patients refused to accept genetic testing. -
Key Trial Info
Start Date :
June 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05969938
Start Date
June 21 2023
End Date
August 31 2024
Last Update
August 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
WeiWei Xiao
Guangzhou, Guangdong, China, 510060