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Trial Title:
Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology
NCT ID:
NCT05969938
Condition:
Rectal Adenocarcinoma
Circulating Tumor DNA
Minimal Residual Disease
Neoadjuvant Chemoradiotherapy
Conditions: Official terms:
Neoplasm, Residual
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MRD detection
Description:
Peripheral blood samples were collected for MRD detection before neoadjuvant
chemoradiotherapy, during neoadjuvant chemoradiotherapy, and 3-4 weeks after radical
surgery. For patients who achieved cCR after neoadjuvant therapy and adopted the W & W
strategy, the sampling time point was 3 months after the start of watching and waiting.
Arm group label:
Treatment group
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 detection in evaluating the prognosis of patients. In this
prospective study, 50 patients with stage II-III rectal cancer who are planing to receive
neoadjuvant chemoradiotherapy will be enrolled. The tumor tissue will be collected by
colonoscopy before treatment and blood samples will be collected before treatment and
during treatment.The whole blood samples will receive MRD detection. The change rate and
clearance rate of MRD during treatment will be calculated, and will be associated with
imaging efficacy evaluation, pathological efficacy evaluation,and prognosis, to determine
the performance of MRD in predicting and judging the efficacy of neoadjuvant
chemoradiotherapy and postoperative recurrence of rectal cancer.
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 collected by colonoscopy biopsy for WES and customized panel design,
and peripheral blood samples will be collected for baseline MRD detection ( MRD1 ) and
during neoadjuvant concurrent chemoradiotherapy ( MRD2-6 ) .Peripheral blood sample will
be collected 3-4 weeks after radical surgery ( MRD7 ). For patients who achieved cCR
after the end of neoadjuvant therapy and adopted the W & W ( watch and wait ) strategy,
the sampling time point was 3 months after the start of watching and waiting ( MRD7 ).
Criteria for eligibility:
Study pop:
This study intends to include 50 patients with stage II-III rectal cancer who plan to
receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age 18-75
2. Rectal adenocarcinoma confirmed by pathology
3. The clinical stage is II-III.
4. Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose
to wait for observation ).
5. ECOG 0-1;
6. No distant metastasis ;
7. Main organ function is normal ;
8. signed informed consent and willing to accept long-term follow-up；
9. No anti-tumor treatment was received within 4 weeks before baseline sampling ;
10. 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 Criteria:
1. unable to provide sufficient tissue / blood samples to meet the research needs ;
2. received radiotherapy, chemotherapy, or other targeted or immunotherapy before
enrollment ;
3. Patients did not receive neoadjuvant therapy according to the original plan ;
4. Patients refused to accept genetic testing. -
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
WeiWei Xiao
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
WeiWei Xiao
Phone:
+8613710390520
Email:
xiaoww@sysucc.org.cn
Start date:
June 21, 2023
Completion date:
August 31, 2024
Lead sponsor:
Agency:
WeiWei Xiao
Agency class:
Other
Collaborator:
Agency:
Haplox Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05969938
