MRD Test in Common Risk Stage II Colorectal Cancer

Stage II Colorectal Cancer Clinical Trial

— HuaMC-1  

Official title:

Observation of MRD Detection for Preoperative Sensitivity and Postoperative Positive Rate in Common Risk Stage II Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05795010
• Other study ID #: XJTU1AF2023LSK-174
• Status: Not yet recruiting
• Start date: March 30, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yongchun Song, MD
• Phone: 0086-18991232549
• Email: 758327495[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage II Colorectal Cancer

Intervention

Other:
• MRD test
ctDNA detection based on tumor whole exon sequencing

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528. Erratum In: JAMA Oncol. 2019 Jun 13;: — View 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. — View 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, Kin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of preoperative MRD test	To observe the positive rate of preoperative MRD detection for stage II colorectal cancer	six months
Secondary	Positive rate of MRD test 1 month and 3 months after operation	Observe the positive rate of MRD detection at 1 month and 3 months after operation for stage II colorectal cancer	nine months