MRD Test in Common Risk Stage II Colorectal Cancer

NCT ID: NCT05795010

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2023-09-30

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.

Conditions

Stage II Colorectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

MRD test

ctDNA detection based on tumor whole exon sequencing

Intervention Type: OTHER

Other Intervention Names

ctDNA test

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongchun Song, MD

Role: STUDY_CHAIR

First Affiliated Hospital of Xian Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Yongchun Song, MD

Role: CONTACT

758327495@qq.com

0086-18991232549

Gang Xu, MD

Role: CONTACT

0086-15829030108

Facility Contacts

Yongchun Song, MD

Role: primary

758327495@qq.com

0086-18991232549

Gang Xu, MD

Role: backup

0086-15829030108

References

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.

Reference Type: BACKGROUND

PMID: 31070691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35750857 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35657320 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

XJTU1AF2023LSK-174

Identifier Type: -

Identifier Source: org_study_id