The Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT04230018
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.

Detailed Description

The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents. Now NCCN guidelines recommend targeted drugs for the treatment of metastatic colorectal cancer mainly including cetuximab and panizumab whic targeting EGFR , as well as the bevacizumab and arber regofini, etc which targeing anti-angiogenic.Cetuximab and panizumab are only effective in patients with RAS wild type.

Previous studies have shown that In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.

Therefore, it has important clinical significance to compare the difference of gene profile between metastatic lesion and primary lesion in patients with postoperative metastasis of stage III colorectal cancer.

Study Timeline

• Study Start: 2018-12-28
• Study First Submitted: 2019-10-28
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-11
• Last Update Submitted: 2020-01-17
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-22
• Primary Completion: 2021-12-27
• Study Completion: 2021-12-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age ≥ 18 years old and ≤ 75 years old, both men and women;
2. Patients must have histologically confirmed metastatic colorectal adenocarcinoma and metastases can be punctured by interventional evaluation;
3. ECOG: 0 to 2;
4. Expected survival ≥ 12 weeks;
5. Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; Hemoglobin ≥ 8g / dL; Platelets ≥100×109/L;(According to the normal value of the clinical trial center)
6. Prothrombin time (PT) < 1.5 times the upper normal limit and thrombin time (APTT) < 1.5 times the upper normal limit;
7. Informed consent has been signed.

Exclusion Criteria

1. Patients had surgery within three weeks will be excluded.
2. Patients have known or suspected brain metastases will be excluded.
3. Pregnant or nursing women will be excluded.
4. Patients with severe uncontrolled systemic disease, such as severe active infection, will be excluded.
5. Patients had other malignancies in the past 5 years will be excluded, except cervical carcinoma in situ or basal cell carcinoma of the skin.
6. Patients who were unable to complete the study or sign valid informed consent for medical, social or psychological reasons, which will be determined by researcher, will be excluded.
7. Organ transplant recipients who need immunosuppressive therapy will be excluded.
8. People have been known to be infected with immunodeficiency virus (HIV) or have been known to be serologically positive for HIV will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis	through study completion, an average of 2 years.	We do NGS sequencing of both the primary and metastatic tissue sample of the CRC patients. The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be compared.

Secondary Outcome Measures

Name	Time	Method
Mutation Consistency of tissue and blood sample	through study completion, an average of 2 years.	The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be reported. The consistency between the gene mutation of ctDNA test in blood and the gene mutation of tissue test is analyzed to determine whether the blood ctDNA test could replace the tissue gene test

Trial Locations

Locations (1)

Cancer center of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China