MRD Test in Common Risk Stage II Colorectal Cancer

NCT05795010 | Unknown

• 1 other identifier: XJTU1AF2023LSK-174
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage II Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Positive rate of preoperative MRD test

  To observe the positive rate of preoperative MRD detection for stage II colorectal cancer

  six months

Secondary Outcomes (1)

• Positive rate of MRD test 1 month and 3 months after operation

  nine months

Interventions

MRD test OTHER

ctDNA detection based on tumor whole exon sequencing

Also known as: ctDNA test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related 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.

  PMID: 31070691 BACKGROUND

• 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.

  PMID: 35750857 BACKGROUND

• 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.

  PMID: 35657320 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and venous blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yongchun Song, MD

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yongchun Song, MD

CONTACT

0086-18991232549; 758327495@qq.com

Gang Xu, MD

CONTACT

0086-15829030108

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 3, 2023
• Study Start: March 30, 2023
• Primary Completion: April 10, 2023
• Study Completion: September 30, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

CN (1)