MRD Application in Colorectal Cancer Patients

ctDNA Monitoring Cancer Recurrence and Its Clinical Value in Solid Tumor

We first collect tumor tissue and adjacent tissue to peform the WES sequencing, then collect blood after postoperative surgery 1, 3. 6, 9, 12, 18, 24 month to detect ctDNA.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Surgery; Chemotherapy Effect

Detailed Description

ctDNA is obtained from plasma rather than serum, as the latter contains more DNA released from immune cells during clotting. Blood should be drawn into a K2EDTA or cell stabilization tube (e.g., Streck cfDNA collection tube). Plasma isolation should be performed as soon as possible, no later than 24 hours, using K2EDTA (preferably within 4-6 hours) and, if using cell stabilization tubes, within 2-7 days, temporarily stored at 4°C.

Sample disposal procedure: collect whole anticoagulated blood, gently invert to fully anticoagulate, plasma fractionation should be performed as soon as possible, no later than 24 hours, temporarily stored at 4°C using K2EDTA (preferably within 4-6 hours), and stored at -80°C for long term. The collected anticoagulant blood is placed in an ice box containing ice packs and transported vertically to a centrifugable laboratory. Centrifuge at 3000 rpm at 4°C for 15 min, take the upper layer, and aliquot 0.5 mL/tube into 1.5 mL centrifuge tubes. Cryopreserved at -80 °C, 1 mL of whole blood yields approximately 0.5 mL of plasma.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Manfei Liang, PhD; Phone Number: 0531-59556161; Email: manfeiliang@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250017
      • Recruiting
      • Jinan Central Hospital Affiliated to Shandong First Medical University
      • Contact: Manfei Liang, PhD; Phone Number: 0531-59556161; Email: manfeiliang@sina.com
      • Contact: Guoqin Liu
      • Principal Investigator: Manfei Liang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer and they were received routine laparoscopic surgery and regular chemotherapy.

Description

Inclusion Criteria:

(1) Patients with colorectal tumors, whose clinical symptoms meet the diagnostic criteria of colon cancer in my country, and pathologically diagnosed as colorectal cancer after surgery; (2) patients with stage II-III colorectal cancer; (3) aged 30-80 years; (4) All underwent conventional radiotherapy and chemotherapy after operation; (5) Complete clinical data and follow-up records were available.

Exclusion Criteria:

• (1) Other serious diseases (cardiovascular and cerebrovascular diseases, kidney diseases, etc.) before operation; (2) Combined with multiple primary colorectal cancers; (3) Patients with other malignant tumors within the past 5 years; (4) Combined with digestive tract Obstruction, perforation, bleeding and other indications for emergency surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA positive patients are detedcted before PET-CT	multiple PCR based on the WES results	2023.12.31

Collaborators and Investigators

• Sponsor: Shandong First Medical University
• Collaborators: Jinan Central Hospital
• Investigators: Study Director: Tao Xu, PhD, Shandong First Medical University

Publications and helpful links

General Publications

• Zhou J, Wang C, Lin G, Xiao Y, Jia W, Xiao G, Liu Q, Wu B, Wu A, Qiu H, Zhang F, Hu K, Xue H, Shen Z, Wang Z, Han J, Niu B, Xu Y, Yu Z, Yang L. Serial Circulating Tumor DNA in Predicting and Monitoring the Effect of Neoadjuvant Chemoradiotherapy in Patients with Rectal Cancer: A Prospective Multicenter Study. Clin Cancer Res. 2021 Jan 1;27(1):301-310. doi: 10.1158/1078-0432.CCR-20-2299. Epub 2020 Oct 12.
• Chen G, Peng J, Xiao Q, Wu HX, Wu X, Wang F, Li L, Ding P, Zhao Q, Li Y, Wang D, Shao Y, Bao H, Pan Z, Ding KF, Cai S, Wang F, Xu RH. Postoperative circulating tumor DNA as markers of recurrence risk in stages II to III colorectal cancer. J Hematol Oncol. 2021 May 17;14(1):80. doi: 10.1186/s13045-021-01089-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: September 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: Manfei01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be available when our paper is accepted.

Drug and device information, study documents

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