Clinical trial NCT05795010: MRD Test in Common Risk Stage II Colorectal Cancer
Official title: Observation of MRD Detection for Preoperative Sensitivity and Postoperative Positive Rate in Common Risk Stage II Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage II Colorectal Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
First posted: 2023-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Positive rate of preoperative MRD test
timeFrame: six months
Secondary outcomes:
measure: Positive rate of MRD test 1 month and 3 months after operation
timeFrame: nine months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yongchun Song, MD
role: STUDY_CHAIR
References:
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citation: Romero D. ctDNA guides omission of adjuvant chemotherapy for stage II CRC. Nat Rev Clin Oncol. 2022 Aug;19(8):493. doi: 10.1038/s41571-022-00657-7. No abstract available.
citation: Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.