MRD Application in Colorectal Cancer Patients

NCT ID: NCT06028516

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer Surgery Chemotherapy Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinan Central Hospital

OTHER

Sponsor Role collaborator

Shandong First Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Xu, PhD

Role: STUDY_DIRECTOR

Shandong First Medical University

Locations

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Jinan central hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Manfei Liang, PhD

Role: CONTACT

0531-59556161

Facility Contacts

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Manfei Liang, PhD

Role: primary

0531-59556161

Guoqin Liu

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 33046514 (View on PubMed)

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.

Reference Type RESULT
PMID: 34001194 (View on PubMed)

Other Identifiers

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Manfei01

Identifier Type: -

Identifier Source: org_study_id

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