MRD Application in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

ctDNA Monitoring Cancer Recurrence and Its Clinical Value in Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028516
• Other study ID #: Manfei01
• Status: Recruiting
• Start date: January 6, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Shandong First Medical University
• Contact: Manfei Liang, PhD
• Phone: 0531-59556161
• Email: manfeiliang[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Locations

Country	Name	City	State
China	Jinan central hospital affiliated to Shandong First Medical University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong First Medical University	Jinan Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA positive patients are detedcted before PET-CT	multiple PCR based on the WES results	2023.12.31