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Trial Title:
MRD Test in Common Risk Stage II Colorectal Cancer
NCT ID:
NCT05795010
Condition:
Stage II Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
MRD test
Description:
ctDNA detection based on tumor whole exon sequencing
Other name:
ctDNA test
Summary:
Patients with colorectal cancer who were confirmed as stage II general risk type in the
postoperative pathological report began to be enrolled. Observe the sensitivity of the
detection of micro-MRD before operation and the postoperative positive rate of this type
of patients.
Detailed description:
This observation part is about the patients with general risk stage II colorectal cancer
who have received R0 resection after screening by nanofiltration criteria. Twenty
milliliters of venous blood samples were reserved before surgery, and tumor tissue
samples were reserved within 30 minutes in vitro during surgery. After the pathological
diagnosis of the patients after surgery, they began to be enrolled. To observe the
sensitivity of MRD detection in preoperative diagnosis of patients with general risk
stage II colorectal cancer, and to study its positive rate one month and three months
after operation.
Criteria for eligibility:
Study pop:
Preoperative venous blood and intraoperative tumor tissue samples were reserved for
patients with colorectal cancer who were estimated as stage II general risk type by
pelvic magnetic resonance imaging. Patients with colorectal cancer who were confirmed as
stage II general risk type in the postoperative pathological report began to be enrolled
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age 18-75;
- Pathologically confirmed rectal adenocarcinoma;
- Pathological differentiation is highly or moderately differentiated;
- The pathological stage was pT3N0, that is, invasion of the proper muscular layer of
the intestinal wall without lymph node metastasis;
- No new adjuvant treatment before operation
- There was no vascular infiltration and nerve infiltration in postoperative
pathology;
- No preoperative intestinal obstruction or tumor site perforation;
- No postoperative pathological margin was positive or unknown;
- The distance between the pathological cutting edge and the tumor was more than 1 cm;
- Invasion of mesentery of intestinal wall ≤ 2mm;
- More than 12 lymph nodes were submitted for examination;
- Nonlocal recurrence and distant metastasis;
- No multiple primary carcinoma of colon and rectum;
- Physical condition score PS ≤ 2 points;
- Patients and their families can understand and are willing to participate in this
study and provide written informed consent.
Exclusion Criteria:
- Multiple intestinal carcinomatosis
- Previous history of malignant tumor,
- There are concurrent malignant tumors in the whole body except for colorectal cancer
- Colorectal cancer with preoperative anti-tumor treatment
- Pregnant or lactating women
- There are serious complications during or after operation, affecting the prognosis
- Hepatitis B or Hepatitis C antibody positive
- HIV antibody positive
- Other diseases considered by the research doctor to affect the prognosis and
survival
- Other conditions that the research doctor believes are not consistent with this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Xian Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Contact:
Last name:
Yongchun Song, MD
Phone:
0086-18991232549
Email:
758327495@qq.com
Contact backup:
Last name:
Gang Xu, MD
Phone:
0086-15829030108
Start date:
March 30, 2023
Completion date:
September 30, 2023
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05795010
