MRD Test in Common Risk Stage II Colorectal Cancer (HuaMC-1)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stage II Colorectal Cancer
• Intervention / Treatment: Other: MRD test

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Yongchun Song, MD; Phone Number: 0086-18991232549; Email: 758327495@qq.com
• Study Contact Backup: Name: Gang Xu, MD; Phone Number: 0086-15829030108

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xian Jiaotong University
      • Contact: Yongchun Song, MD; Phone Number: 0086-18991232549; Email: 758327495@qq.com
      • Contact: Gang Xu, MD; Phone Number: 0086-15829030108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of preoperative MRD test	To observe the positive rate of preoperative MRD detection for stage II colorectal cancer	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University
• Investigators: Study Chair: Yongchun Song, MD, First Affiliated Hospital of Xian Jiaotong University

Publications and helpful links

General Publications

• 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;:
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2023
• Primary Completion (Anticipated): April 10, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: XJTU1AF2023LSK-174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will be published anonymously after the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No